(55 days)
No
The device description and intended use are for a dental cement, and there is no mention of AI or ML in the provided text.
No
The device is a dental cement used for cementing restorations, which is not considered a therapeutic device. It is primarily for mechanical attachment rather than treating a disease or condition.
No
The device description clearly states it is a "self-etch adhesive resin cement" used for "cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts," indicating its function is restorative, not diagnostic.
No
The device description clearly states it is a physical material (self-etch adhesive resin cement) supplied in syringes, indicating it is a hardware 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 for the cementation of dental restorations (inlays, onlays, crowns, bridges, and posts). This is a direct application within the body for structural support, not for testing or analyzing samples taken from the body.
- Device Description: The description details a dental cement, its composition, and how it's dispensed. This aligns with a material used in dental procedures, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely restorative and structural within the oral cavity.
N/A
Intended Use / Indications for Use
Cement-It All Purpose product performs the same intended function as its predicate device, MaxCem (reference K041474). Both devices are intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. Both devices are not recommended for use on veneer restorations.
Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
Product codes
EMA
Device Description
The subject device is a self-etch adhesive resin cement in a catalyst/base paste formulation and is a dual cure luting agent. Due to its self-etching and adhering properties, Cement-It All Purpose does not require the use of an etchant, primer or adhesive.
Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Cement-It All Purpose is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features.
Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.
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
A review for safety and effectiveness was performed and found not to have been affected.
Key Metrics
Not Found
Predicate Device(s)
MaxCem (reference K041474)
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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters that appear to be a combination of letters and numbers. The string reads 'K060698'. The characters are written in a dark ink on a white background, and the handwriting is somewhat stylized.
Image /page/0/Picture/1 description: The image contains the logo for Pentron Clinical Technologies, LLC. The logo features a stylized graphic to the left of the text. The graphic is composed of horizontal lines that form a shape resembling a water droplet or a stylized tree.
cing dentistry one Innovation at a time."
MAY 10 2006
6.0 510(K) SUMMARY
Pentron Clinical Technologies, LLC, 68 North Plains Industrial Road Wallingford, CT 06492 Tel: 203-265-7397 Fax: 203-265-3074 Contact: Greg Moreau =============================================================================================================================================================================
Trade Name: Cement-It All Purpose Common Name: Dental resin cement Classification Name: Dental Cement, 21CFR 872.3275, EMA ==============================================================================================================================================================================
Cement-It All Purpose product performs the same intended function as its predicate device, MaxCem (reference K041474). Both devices are intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. Both devices are not recommended for use on veneer restorations.
The subject device is a self-etch adhesive resin cement in a catalyst/base paste formulation and is a dual cure luting agent. Due to its self-etching and adhering properties, Cement-It All Purpose does not require the use of an etchant, primer or adhesive.
Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Cement-It All Purpose is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features.
Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.
A review for safety and effectiveness was performed and found not to have been affected.
510(k) Submission for Cement-It All Purpose
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure with three curved lines representing the body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 10 2006
Mr. Greg Moreau Director, Quality Systems Pentron Clinical Technologies, LLC 68 North Plains Industrial Road Wallingford, Connecticut 06492
Re: K060698
Trade/Device Name: Cement-It All Purpose Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: April 28, 2006 Received: May 03, 2006
Dear Mr. Moreau:
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.
2
Page 2 - Mr. Greg Moreau
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Chu S. Lin, PhD
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (if KNOWN):
DEVICE NAME: Cement-It All Purpose
INDICATION FOR USE:
Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | ----------------------------------------------------- |
OR
| Over-The-Counter-Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
510(k) Submission for Cement-It All Purpose
(Signature Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices