(79 days)
K 002364
Not Found
No
The 510(k) summary describes a dental cement and its delivery system. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical and chemical properties.
No.
The device is a dental cement intended for affixing dental devices like crowns and bridges, not for treating a disease or condition.
No
Explanation: The device, Unicem, is a dental cement intended for affixing dental devices like crowns and bridges. Its purpose is to physically bond dental prosthetics, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a dental cement composed of various materials and available in different physical delivery systems (Aplicap™, Maxicap™, Clicker™). This indicates a physical, material-based device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneers and orthodontic strips." This describes a device used in vivo (within the body) for dental restoration and orthodontics.
- Device Description: The description clearly states it's a "Dental cement" used to "affix dental devices such as crowns and bridges." This is a material used directly on or in the patient's mouth.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of Unicem does not involve any such testing or analysis of biological samples.
Therefore, Unicem is a dental device used for adhesive purposes in dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneers and orthodontic strips.
Product codes
EMA
Device Description
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 oxideeugenol. Unicem is intended to affix dental :.cvices such as crowns and bridges. Unicem currently is available in two single dose delivery systems called Unicem Aplicap™ and Unicem Maxicap™. The existing and 510(k) cleared device Unicem is modified as follows: A multi-dose handmix version of Unicem, called Unicem HM, will be added to the single dose delivery systems. Unicem HM is considered as a modification to its predicate device Unicem. Unicem HM consists of a base and catalyst base and will be available in 3M ESPE's multi-dose device Clicker™. The intended use of Unicem HM is the same as cleared for Unicem, and the slight differences in chemical composition have been assessed for any effects regarding biocompatibility. The physical and chemical properties of Unicem HM were compared to those of Unicem. Furthermore, the physical-chemical property to release fluoride ions is added to the product description of Unicem. For this purpose, the fluoride release rates of Unicem have been measured following the guidance document: "Dental Cements - Premarket Notification" issued by CDRH on August 18, 1998, section 6.0. In summary, Unicem modified as described in this 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The physical and chemical properties of Unicem HM were compared to those of Unicem. Furthermore, the physical-chemical property to release fluoride ions is added to the product description of Unicem. For this purpose, the fluoride release rates of Unicem have been measured following the guidance document: "Dental Cements - Premarket Notification" issued by CDRH on August 18, 1998, section 6.0.
Key Metrics
Not Found
Predicate Device(s)
Unicem by 3M ESPE, K 002364
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
0CT 2 5 2006
Submitter
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann, |
| Manager Regulatory Affairs | |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | andreas.petermann@mmm.com |
| Date: | August 02, 2006 |
.
1
Name of Device
Proprietary Name: Classification Name: Common Name:
Unicem Dental cement other than zinc oxide-eugenol Scif adhesive cement
Predicate Device
Unicem by 3M ESPE, K 002364
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 than zinc oxideeugenol. Unicem is intended to affix dental :.cvices such as crowns and bridges. Unicem currently is available in two single dose delivery systems called Unicem Aplicap™ and Unicem Maxicap™. The existing and 510(k) cleared device Unicem is modified as follows: A multi-dose handmix version of Unicem, called Unicem HM, will be added to the single dose delivery systems. Unicem HM is considered as a modification to its predicate device Unicem. Unicem HM consists of a base and catalyst base and will be available in 3M ESPE's multi-dose device Clicker™. The intended use of Unicem HM is the same as cleared for Unicem, and the slight differences in chemical composition have been assessed for any effects regarding biocompatibility. The physical and chemical properties of Unicem HM were compared to those of Unicem. Furthermore, the physical-chemical property to release fluoride ions is added to the product description of Unicem. For this purpose, the fluoride release rates of Unicem have been measured following the guidance document: "Dental Cements - Premarket Notification" issued by CDRH on August 18, 1998, section 6.0. In summary, Unicem modified as described in this 510(k) premarket notification submission is, in our opinion, substantially equivalent to the predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Sabine Krischer Regulatory Affairs Specialist 3M ESPE Dental Products ESPE Platz Seefeld, Bavaria Germany D-82229
OCT 2 5 2006
Re: K062292
Trade/Device Name: Unicem Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 3, 2006 Received: August 7, 2006
Dear Dr. Krischer:
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 Eederal Register.
3
Page 2 - Dr. Krischer
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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Sibe Kun
Chiu Lin, Ph.D.
Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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STATEMENT OF INDICATIONS FOR USE
Device Name:
Unicerı
Indications for use:
Adhesive fixing of ceramic, composite or metal inlays, onlays, crowns, bridges, posts, screws, veneers and orthodontic strips.
[The official form "Indications for Use" is to be found in the Administrative Part of this application]
Sue Panor
4 Anesthe slotogy, General Hospital, on Contro: L
510(k) Number: K062222