(45 days)
Not Found
No
The device description and intended use are for a temporary dental cement, and there is no mention of AI or ML in the provided text.
No
The device is a temporary cement used for dental restorations, not a therapeutic device designed to treat or cure a disease or condition.
No
The document describes a temporary cement used for bonding dental restorations. It does not describe a device used for diagnosing a medical condition.
No
The device is a temporary resin cement, which 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 clearly describes the device as a temporary cement for dental restorations (crowns, bridges, etc.) on prepared teeth or implant abutments. This is a therapeutic or restorative use, not a diagnostic one.
- Device Description: The description details a temporary resin cement used for bonding dental restorations. This aligns with a dental material, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (blood, urine, tissue, etc.) or to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is to physically bond dental restorations.
N/A
Intended Use / Indications for Use
INTEGRITY™ TEMPORARY CFMENT is indicated for: 1) temporary cementation of provisional acrylic and composite indirect restorations to prepared teeth or implant abutments; 2) provisional or trial cementation of ccramic, porcelain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to prepared tecth or implant abutments; and 3) ccmentation of ceramic, porcclain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to implant abutments and telescopic fixed restorations which require periodic removal for maintenance, etc.
Product codes
EMA
Device Description
INTEGRITY™ TEMPORARY CEMENT is a dual-cured or selfcured temporary resin cement for use with provisional crown and bridge restorations. The cement is dispensed from a dual barrel 5 ml syringe for hand-mixing on a mix pad or for use with an automix tip. It is then polymerized by dual curing. Visible light initiators are used for self-curing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prepared teeth or implant abutments
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
Not Found
Key Metrics
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
MAY 2 1 2004
510(k) SUMMARY
NAME & ADDRESS: DENTSPLY International World Headquarters Susquehanna Commerce Ctr. 221 West Philadelphia Street York, PA 17405-0872 (717) 845-7511 (voice) (717) 849-4762 (fax) www.dentsply.com
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
March 30, 2004 DATE PREPARED:
INTEGRITY™ TEMPORARY CEMENT TRADE OR PROPRIETARY NAME:
Dental cement (872.3275) CLASSIFICATION NAME:
PREDICATE DEVICES: BIOMER™ Composite Luting Ccmcnt (K853431) T.E.R.M.TM VI.C Temporary Endo Restorative Material (K854253)
DEVICE DESCRIPTION: INTEGRITY™ TEMPORARY CEMENT is a dual-cured or selfcured temporary resin cement for use with provisional crown and bridge restorations. The cement is dispensed from a dual barrel 5 ml syringe for hand-mixing on a mix pad or for use with an automix tip. It is then polymerized by dual curing. Visible light initiators are used for self-curing.
INTENDED USE: INTEGRITY™ TEMPORARY CFMENT is indicated for: 1) temporary cementation of provisional acrylic and composite indirect restorations to prepared teeth or implant abutments; 2) provisional or trial cementation of ccramic, porcelain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to prepared tecth or implant abutments; and 3) ccmentation of ceramic, porcclain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to implant abutments and telescopic fixed restorations which require periodic removal for maintenance, etc.
TECHNOLOGICAL CHARACTERICS: All of the components found in INTEGRITY™ TEMPORARY CEMENT have been used in legally marketed devices or were found safe for INTEGRITY™ TEMPORARY CEMENT has been evaluated and passed dental use. biocompatibility testing for cytotoxicity, acute oral toxicity, mutagenicity, irritation and sensitization.
We believe that the prior use of the components of INTEGRITY™ TEMPORARY CEMENT in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of INTEGRITY™ TEMPORARY CEMENT for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2004
Dentsply International Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Susgehanna Commerce Center West 221 West Philadelphia Street York, Pennsylvania 17405-0872
Re: K040895
Trade/Device Name: INTEGRITY™ TEMPORARY CEMENT Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EMA Dated: March 30, 2004 Received: April 6, 2004
Dear Mr. Lehn:
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 (Spccial Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 mr.), it inst (1 may of a 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. Lehn
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 modi that I Dri mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ouchar the Act's requirements, including, but not limited to: registration 1 ou intist comply with and 807); labeling (21 CFR Part 801); good manufacturing practice allu instille (21 OF RT rav 007), absitiss systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form in are qt 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) This letter will anon you The FDA finding of substantial equivalence of your device to a premaired predicated. - 11 - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specific at .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 may obtain 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,
Signature
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 STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
INTEGRITY™ TEMPORARY CEMENT Device Name:
Indications for Use:
INTEGRITY™ TEMPORARY CEMENT is indicated for:
-
- Temporary cementation of provisional acrylic and composite indirect restorations to prepared tecth or implant abutments.
-
- Provisional or trial cementation of ceramic, porcelain, composite, PFM (porcelain fuscd to metal) and all metal crowns and bridges to prepared teeth or implant abutments.
- Cementation of ceramic, porcelain, composite, PFM (porcelain fused to metal) and all metal 3. crowns and bridges to implant abutments and telescopic fixed restorations which require periodic removal for maintenance, etc.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sosa Suarez
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number
l'remarket Notification INTEGRITYIN ITMPORARY CEMENT DENTSPLY International