(71 days)
Not Found
No
The 510(k) summary describes a dental cement and does not mention any AI or ML components.
No
The device is a Self-adhesive Resin Cement, an indirect restorative material used for cementation purposes, not for treating diseases, injuries, or medical conditions.
No
Explanation: The device is a resin cement used for the cementation of dental restoratives. It does not diagnose any condition or disease.
No
The device description clearly states it is a "Self-adhesive Resin Cement" consisting of pastes and delivered in syringes, indicating it is a physical material, not software.
Based on the provided information, 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 (or on a part of the body) for a therapeutic or restorative purpose.
- Device Description: The device is a resin cement, a material used to bond dental prosthetics.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Being used for diagnosis, monitoring, or screening.
IVDs are used to perform tests on samples taken from the body to provide information about the body's condition. This device is a material used on the body for a structural purpose.
N/A
Intended Use / Indications for Use
Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.
Product codes
EMA
Device Description
Self-adhesive Resin Cement consists of a base paste and a catalyst paste, mixed to form a dual-curing cement. The Cement is available in five shades and is delivered in double-barrel syringes and unit dose systems.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Self-adhesive Resin Cement has been evaluated and passed biocompatibility testing for cytotoxicity, genotoxicity, irritation and sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K073173
510(k) SUMMARY
DENTSPLY Internation Susquehanna Commerce Center We 221 West Philadelphia Street, Suite ( York, PA 17405-08
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | November 8, 2007 |
| TRADE OR PROPRIETARY NAME: | Self-adhesive Cement |
| CLASSIFICATION NAME: | Dental cement, 21 CFR 872.3275 |
| PREDICATE DEVICES: | Unicem, K020256 and MaxCem, K041474 |
JAN 2 3 2008DEVICE DESCRIPTION: Self-adhesive Resin Cement consists of a base paste and a catalyst paste, mixed to form a dual-curing cement. The Cement is available in five shades and is delivered in double-barrel syringes and unit dose systems.
Unicem, K020256 and MaxCem, K041474
INTENDED USE:
Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in Self-adhesive Resin Cement have been used in legally marketed devices and/or were found safe for dental use. Self-adhesive Resin Cement has been evaluated and passed biocompatibility testing for cytotoxicity, genotoxicity, irritation and sensitization.
We believe that the prior use of the components of Self-adhesive Resin Cement in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of Self-adhesive Resin Cement for the indicated uses.
1
JAN 23 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K073173
Trade/Device Name: Self-Adhesive Resin Cement Regulation Number: 21 CFR 872.3275 (b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: November 8, 2007 Received: November 13, 2007
Dear Ms. Lewis:
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 - Ms. Lewis
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" (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,
Sylite Y. Michie Davis.
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
3
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Self-adhesive Resin Cement
Indications for Use:
Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.
1073173
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE----CONTINUE ON ANOTHER PAGE IF NEEDI !)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073173
Self-adhesive Resin Cement