FDA for Curing Light: 510(K) Number: K080025, Regulation Number: 21 CFR 872.6070, Product Code: EBZ
- Item Show
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- Features
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Features:
Input voltage: AC 100-240V, 50-60HZ
Adapter voltage: 5V 1A
LED power: 5W
Battery capacity: 2000mA
Light intensity: 150000Lux
Weight: 1300g Net weight: 160g
Package size: 33*20*10 CM
Working distance: 420mm
Depth of field: 90mm
Depth of vision: 100mm
Magnification:5.0X
Getting Started With Your New Loupe
It is common for new users of magnification to experience some initial disorientation. This may also occur
when increasing from a lower magnification povver to higher powered lou pes. In such cases, a tvvo to three
week acclimation period is recommended. If you initially experience dizziness, wear your lou pe for no more
than one hour at a time and start by performing simple procedures. As your eyes adapt to a magnified field
and your hand-eye coordination develops, gradually extend the time you wear your loupe. Fine-tune the pupillary distance of your telescopes by rotating the pupillary distance (PD) knob on the hinge to adjust the distance betvveen telescopes to align vvith your eyes.
Indications for Use
Loupes are a magnification device, worn as a visual aid, intended to magnify oral cavities and operating
sites. This device is intended to only be used by qualified medical and healthcare professionals including,
but not limited to, dentists, dental hygienists, medical doctors and medical professionals.
Cleaning and Disinfecting
Your loupe is a precision optical instrument manufactured from high quality components. With proper
care, it vvill provide a long and useful life. You must adhere to the following instructions for proper
cleaning and disinfecting, or damage may result.
DO NOT
• Do not spray directly onto the device
• Do not run any part of the device under water or submerge in any liquid or ultrasonic cleaner
• Do not use an autoclave, chemiclave, glutaraldehyde, iodophor, or any other sterilization method
• Do not use a cleaner with alcohol concentration greater than 70%
• Do not use a paper towel to clean the lenses
Package List:
5.0X Loupes * 1
1.5X Magnifier *1
Calor changing lampshade*2
Battery *2
Charging rack* 1
Charger* 1
- Notice
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Parts of items have different voltage (110V or 220V), we will ship out the items with corresponding voltage according to the country shown on the shipping address on ebay.
- Statement (FDA)
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The sale of this item may be subject to regulation by the U.S. Food and
Drug Administration and state and local regulatory agencies. If the item
is subject to FDA regulation, I will verify your status as an
authorized purchaser of this item before shipping of the item.
- Payment
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a) Paypal accepted.b) Please accomplish payment within 7 days after purchase. If you do have any reason cannot make payment timely, kindly please email me. Otherwise, all unpaid items will be filed an unpaid item dispute through eBay.c) Import duties, taxes and charges are not included in the item price or shipping costs. These charges are the buyer's responsibility. Please check with your country's customs office prior to bidding/buying to determine what these additional costs will be.
- Delivery Details
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We use international Express Shipping Service.
Fedex, DHL, UPS, USPS(over 2KG): 7-12 days.
EUB (under 2KG),YanWen,WanB Express, Orange Connex:
Only for USA, Canada, and Japan. 12-15 days.
Other Countries 15-25 days.
Note: We can offer the tracking number for u to check the status of your item in 2 days after we deliver it. For international shipping, customs duties might be possible for some countries, they are buyers'responsibility, Hope his could be understood. S&H charged dose not include any those fees. We are not responsibility for the delay of clearance in the buyer's country, but we will help you clear as suppling some files. If the item is in customs or post office for some days, pls contact with local customs actively, otherwise, if the item returns to us, the buyer will pay for the shipping fee for resend or refund except the shipping fee. Few states need to pay remote surcharge. Don't worry, I will tell you before you pay if it's need.
We only ship to your PayPal address. Please make sure it's correct. You can email us in 1-2 days to change ur shipping address, or we are not responsible for it after we deliver ur products.
- Return Policy
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Your SATISFACTION is our ultimate goal. We work hard to earn your trust and future business.
a) Please check the package first before you sign for the package. If the package has any damage, please file a claim on your local shipping company.b) If you have a defective item, you can return it or ask for a discount. Please contact us within 2 days after you receive the package.c) What you returned must be unused and in the original packaging as received. Customer is responsible for shipping charges on returned items.d) We will refund the money to you when we get the return items. Or replace item for you.
- Terms of Sales
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Please leave us your phone number for smooth and fast delivery.
Our prices does not include any taxes, VAT and other hidden charges.
Buyers should be responsible for your customs duties if there is any.
If you need some profiles, please contact us. We will attach it via Email.
- About us
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We are factory founded dental equipment Wholesaler and Retailer.
We offer 1 full year warranty for most of our items(please contact us for more info).
Each item will be quality checked before shipping to our customers.
- Contact us
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If you have any questions about our service or products. You can send us eBay message or Email.
You will be replied within 24 hours(48 hours in the weekend).
Customer Serivce: Nicole/Shannon/Linda/Candy
ShenZhen.China
FDA for Curing Light: 510(K) Number: K080025, Regulation Number: 21 CFR 872.6070, Product Code: EBZ
The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item.
The item has been cleaned and handled in accordance with the manufacturer's instructions
FDA for Curing Light: 510(K) Number: K080025, Regulation Number: 21 CFR 872.6070, Product Code: EBZ
FDA for Handpiece: 510(K) Number: K181900, Regulation Number: 872.4200, Classification Product Code: EFB
FDA for Scaler: 510(K) Number: K053555, Regulation Number: 872.4850, Product Code: ELC
FDA for Portable Dental Unit: 510(K) Number: K111907, Regulation Number: 872.6640, Product Code: EIA
FDA for Autoclave Sterilizer: 510(K) Number: K231449, Regulation Number: 872.1800, Product Code: EHD
FDA for Endo Motor: 510(K) Number: K203320, Regulation Number: 872.4200, Product Code: EKX
FDA for Apex Locator: 510(K) Number: K181087, Product Code: LQY
Seller name: Nicole
City, State: ShenZhen,China
telephone number:+08618223676824