(84 days)
KaVo PolyLUX II is a handpiece for polymerization and is intended exclusively for dental treatment in regular dentistry.
PolyLUX II is a hand piece with a halogen quartz light source intended for curing dental resins.
The provided document K013500 is a 510(k) summary for a dental curing light, PolyLUX II. The summary explicitly states: "Performance Data: None required. The claim of substantial equivalence is based on comparisons of formulations and intended uses of the claimed predicate."
Therefore, based on the provided text, there is no study conducted to prove the device meets specific acceptance criteria in terms of performance. The regulatory approval was based on demonstrating substantial equivalence to predicate devices, not on a new performance study.
Given this, I cannot extract the information required in the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types and establishment methods for training and test sets) because such performance data and studies were explicitly not required and thus not provided in this 510(k) summary.
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SECTION 9
510(k) SUMMAR Y
JAN 1 4 2002
This 510(k) summary of safety and effectiveness for PolyLUX II is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
- Applicant: KaVo America
- 340 East Main Street Address: Lake Zurich, IL 60045
- Manufacturer: KaVo Dental GmbH Bahnhofstr. 20 D-8847 Warthausen Biberach GERMANY
- Ms. Jennifer Pottala Contact Person:
- Telephone: 847-550-6800 847-550-6825 (Fax) 800-323-8029
Preparation Date: August 2001 (of the Summary)
- PolyLUX II Device Name:
- Dental Curing Light Common Name:
Activator, Ultraviolet, for Polymerization (Class II medical device; (21 CFR Classification: 872.6070).
Product Code: EBS Panel: 76
- Predicate devices: VIP-Variable Intensity Polymerizer (Bisco, Inc.), Elipar FreeLight and TriLight (ESPE Dental AG), Versalux (Centrix, Inc.), Palmlight; Optilux; Avanté (Jeneric/Pentron, Inc.), and Coltolux 3 and 4 (Coltene/Whaledent AG).
Note: In searching company web sites the particular model curing lights cited in the 510(k) data base were not always found but comparable [perhaps] models were noted.
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Device description: PolyLUX II is a hand piece with a halogen quartz light source intended for curing dental resins.
PolyLUX II is a hand piece for polymerization and is intended exclusively Indications: for dental treatment in regular dentistry.
KaVo proposes that the PolyLUX II be labeled:
"CAUTION: Federal (US) law restricts the use of this device to licensed professionals."
068
Performance Data: None required. The claim of substantial equivalence is based on comparisons of formulations and intended uses of the claimed predicate.
CONCLUSION: Based on the information in the notification KaVo America believes that PolyLUX II is substantially equivalent to the claimed predicates.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2002
Ms. Jennifer Pottala Kavo America 340 East Main Street Lake Zurich, Illinois 60047
Re: K013500 Trade/Device Name: KaVo PolyLux II Regulation Number: 872.6070 Regulation Name: Activator, Ultraviolet, For Polymerizations Regulatory Class: II Product Code: EBZ Dated: October 22, 2001 Received: October 22, 2001
Dear Ms. Pottala:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 was ) vice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Ms. Pottala
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: KaYo PolyLUX II
Indications for Use Statement:
KaVo PolyLUX II is a handpiece for polymerization and is intended exclusively for dental treatment in regular dentistry.
KaVo proposes that KaVo PolyLUX II carry the following label:
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | OR | Over-The Counter Use __ | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| Document Number | K013500 |
|---|---|
| ----------------- | --------- |
059
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.