(63 days)
No
The summary describes a dental cement with chemical and physical properties, with no mention of AI/ML or data processing.
No.
The device is a dental cement used for permanent cementation in restorative dentistry, not for therapeutic treatment of diseases or conditions.
No
The device is a dental cement used for permanent cementation of restorations and has no diagnostic indications or functions.
No
The device description clearly indicates it is a two-component dental 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a dental cement used for the permanent cementation of crowns, bridges, and for bonding amalgam to tooth structure. It is applied directly to the tooth and dental restorations.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the patient. Its function is purely mechanical and adhesive within the oral cavity.
Therefore, this device falls under the category of a dental restorative or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ADHESIVE HYBRID IONOMER CEMENT is used for adhesive cementation of: all metal crowns and bridges including precious, semi-precious and non-precious metals, conventional porcelain fused to metal crowns and bridges with metal margins, gold inlays and onlays, prefabricated and cast posts, porcelain/ceramic/composite substrate crowns, porcelain jacket crowns (including foil or electroplated lined crowns), porcelain fused to metal crowns with porcelain margins; and as an adhesive liner for bonding freshly placed direct amalgam restorations.
Product codes
EMA
Device Description
ADHESIVE HYBRID IONOMER CEMENT is a two-component, dualcure, high-strength hybrid ionomer dental cement used for permanent cementation of crowns and bridges, and for adhesive bonding of fresh direct amalgam to tooth structure.
The cured product demonstrates adhesion to dentin and enamel, releases fluoride, and has suitable physical properties required for a dental luting cement, as well as a protective barrier.
The physical properties of ADHESIVE HYBRID IONOMER CEMENT are comparable to Advance® Hybrid Ionomer Cement (K940914).
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)
ADHESIVE HYBRID IONOMER CEMENT (cured material) was tested by the MEM Elution Test and the Ames Mutagenicity Test, and found to be non-cytotoxic and non-mutagenic. A histopathologic study of the effects of the product cured in the teeth of sub-human primates was conducted. All responses were found to be acceptable.
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
510(k) SUMMARY
Image /page/0/Picture/1 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and connected to each other. The word is in black and the background is white.
NAME & ADDRESS:
JAN - 5 1998
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343 P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
October 31, 1997 DATE PREPARED:
ADHESIVE HYBRID IONOMER CEMENT TRADE OR PROPRIETARY NAME:
872.3275 CLASSIFICATION NAME: Dental Cement
K940914 Advance® Hybrid Ionomer Cement PREDICATE DEVICE:
DEVICE DESCRIPTION: ADHESIVE HYBRID IONOMER CEMENT is a two-component, dualcure, high-strength hybrid ionomer dental cement used for permanent cementation of crowns and bridges, and for adhesive bonding of fresh direct amalgam to tooth structure.
The cured product demonstrates adhesion to dentin and enamel, releases fluoride, and has suitable physical properties required for a dental luting cement, as well as a protective barrier.
The physical properties of ADHESIVE HYBRID IONOMER CEMENT are comparable to Advance® Hybrid Ionomer Cement (K940914).
INTENDED USE: ADHESIVE HYBRID IONOMER CEMENT is used for adhesive cementation of: all metal crowns and bridges including precious, semi-precious and non-precious metals, conventional porcelain fused to metal crowns and bridges with metal margins, gold inlays and onlays, prefabricated and cast posts, porcelain/ceramic/composite substrate crowns, porcelain jacket crowns (including foil or electroplated lined crowns), porcelain fused to metal crowns with porcelain margins; and as an adhesive liner for bonding freshly placed direct amalgam restorations.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in ADHESIVE HYBRID IONOMER CEMENT have either been used in legally marketed devices or have been found safe for dental use.
ADHESIVE HYBRID IONOMER CEMENT (cured material) was tested by the MEM Elution Test and the Ames Mutagenicity Test, and found to be non-cytotoxic and non-mutagenic. A histopathologic study of the effects of the product cured in the teeth of sub-human primates was conducted. All responses were found to be acceptable.
We believe that the prior use of the components of ADHESIVE HYBRID IONOMER CEMENT in legally marketed devices, the performance data, and the results of biocompatibility testing support the safety and effectiveness of ADHESIVE HYBRID IONOMER CEMENT for the intended uses.
000044
1
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized lines forming the body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 1998
Mr. Jeffery P. Lehn Director of Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405
Re : K974140 Adhesive Hybrid Ionomer Cement Trade Name: Requlatory Class: II Product Code: EMA Dated: October 31, 1997 Received: November 3, 1997
Dear Mr. Lehn:
We have reviewed-your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Lehn
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
K974/40
510(K) Number: Device Name:
ADHESIVE HYBRID IONOMER CEMENT
ADHESIVE HYBRID IONOMER CEMENT is used for:
- · Adhesive cementation of all metal crowns and bridges including precious, semi-precious and non-precious metals
- · Adhesive cementation of conventional porcelain fused to metal crowns and bridges with metal margins
- · Adhesive cementation of gold inlays and onlays
- · Adhesive cementation of prefabricated and cast posts.
- · Adhesive cementation of porcelain/ceramic/composite substrate crowns
- · Adhesive cementation of porcelain jacket crowns (including foil or electroplated lined crowns)
- · Adhesive cementation of porcelain fused to metal (PFM) crowns with porcelain margins
- · Adhesive liner for bonding freshly placed direct amalgam restorations
| Concurrence of CDRH. Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | P.D. Scast for Susan Runner |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K974140 |
Prescription Use V
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________