(60 days)
Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneers and orthodontic strips
Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275[b]) because it is a device composed of various materials other than zinc oxide-eugenol. Unicem is intended to affix dental devices such as crowns and bridges. Unicem self adhesive luting cement due to its newly developed chemistry combines the advantages of glass ionomer luting cements with esthetic properties of composite luting cements.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) premarket notification summary for a dental cement called Unicem, indicating its substantial equivalence to predicate devices. The document mainly covers:
- Submitter Information: Company details, contact person.
- Device Name: Proprietary, classification, and common names.
- Predicate Devices: A list of existing devices used for comparison.
- Description for Premarket Notification: Details about Unicem, its composition, and its intended use (affixing dental devices). It mentions toxicology testing for biocompatibility and comparison with predicate devices for effectiveness, focusing on physical and mechanical properties.
- FDA Correspondence: A letter from the FDA acknowledging the 510(k) submission and determining substantial equivalence.
- Indications for Use: The specified uses for the Unicem device.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance based on the provided text. The document states that the device was compared to predicate devices for effectiveness based on physical and mechanical properties, and biocompatibility testing was carried out, but it does not detail specific acceptance criteria or the study methodology, sample sizes, ground truth, or expert involvement as requested.
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MAR 2 5 2002
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be 'K020256'. The writing is somewhat rough, with varying line thickness and slight imperfections, giving it a natural, non-digital appearance. The characters are spaced closely together.
11.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Contact: | Dr. Andreas Petermann,Manager U.S. Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| Andreas.Petermann@mmm.com |
Name of Device
| Proprietary Name: | Unicem |
|---|---|
| Classification Name: | Dental cement other than zinc oxide-eugenol |
| Common Name: | Self adhesive cement |
Predicate Devices
| Compolute™ by 3M ESPE | K 974458 |
|---|---|
| Ketac™ Cem by 3M ESPE | K 897188 |
| HAUR™ by 3M ESPE | K 010781 |
| Protemp™ H by 3M ESPE | K 002364 |
| Alkaliner™ by 3M ESPE | K 873882 |
Description for the Premarket Notification
Unicem is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275[b]) because it is a device composed of various materials other
Image /page/0/Picture/12 description: The image shows the text "510(k) Unicem™ 3M ESPE". The text is stacked on top of each other, with "510(k) Unicem™" on the top line and "3M ESPE" on the bottom line. The text is in black and the background is white. The font is sans-serif.
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than zinc oxide-eugenol. Unicem is intended to affix dental devices such as crowns and bridges.
Unicem self adhesive luting cement due to its newly developed chemistry combines the advantages of glass ionomer luting cements with esthetic properties of composite luting cements.
Unicem contains some particular ingredients which are not contained in known predicate devices. To evaluate the biocompatibility of Unicem, toxicology testing has been carried out. To provide evidence for the effectiveness, Unicem was compared to predicate devices in terms of physical and mechanical properties.
In summary, 3M ESPE's new self adhesive luting cement Unicem described in this premarket notification submission is, in our opinion, substantially equivalent to the predicate devices.
The substantial equivalence to the well established products Ketac Cem and Compolute, the performance data and the results of biocompatibility testing provide evidence that safety and effectiveness requirements of Unicem are completely met.
Image /page/1/Picture/5 description: The image shows the text "510(k) Unicem TM 3M ESPE" in black font. The text is stacked on top of each other, with "510(k) Unicem TM" on the top line and "3M ESPE" on the bottom line. The font is simple and easy to read. The image is likely a logo or branding for a product or company.
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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 the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized lines that form a human-like figure, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2002
Dr. Andreas Petermann Manager, U.S. Regulatory Affairs 3M ESPE AG ESPE Platz D-82229 Seefeld Bavaria, GERMANY
Re: K020256
Trade/Device Name: Unicem™M Regulation Number: 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 21, 2002 Received: January 24, 2002
Dear Dr. Petermann:
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 your device 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.
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Page 2 - Dr. Andreas Petermann
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. 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. Ulatowski
Timoth A. Ulatows 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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STATEMENT OF INDICATIONS FOR USE
(As Required by 21 C.F.R. § 801.109)
510(k) Number:
Device Name:
Unicem™
Indications for use:
Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneers and orthodontic strips
Prescription use: �
Over-the counter use □
Susa Busse
Off) Division of Dental, Infection Control, and General Hospital Devices F 10(k) Number _______________________________________________________________________________________________________________________________________________________________ Kappa
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.