(155 days)
Not Found
No
The summary describes light-curing composites and addition-curing silicone materials, with no mention of AI or ML capabilities.
No.
The devices described are materials for temporary dental care (composites) and for verifying the fit of dental prosthetics (silicone). Their intended use is not to treat, cure, mitigate, or prevent disease, but rather to support dental procedures temporarily or diagnostically.
No
The devices are primarily materials for temporary dental procedures (inlays, onlays, cement, etc.) and a silicone for checking fit precision. While fit precision could be seen as an assessment, the overall indicated uses do not involve diagnosing a disease or condition, but rather facilitating or verifying aspects of dental restorations.
No
The device description clearly states the device is composed of light-curing composites and addition-curing silicone, which are physical materials, not software.
Based on the provided information, neither the provisional inlay and onlay materials nor the FitInspector are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended uses described for both products involve direct application within the patient's mouth for temporary dental procedures and checking the fit of dental restorations. They are not used to analyze biological samples like blood, urine, or tissue.
- The descriptions focus on the physical properties and applications of the materials within the oral cavity. The provisional materials are light-curing composites for temporary fillings and cements, and the FitInspector is a silicone for checking the fit of dental prosthetics. These are all direct clinical applications, not laboratory tests on specimens.
Therefore, these devices fall under the category of dental materials and devices used directly in patient care, not in vitro diagnostic products.
N/A
Intended Use / Indications for Use
The Provisional Inlay and Onlay materials are light-curing composites for:
- temporary care of inlay and onlay preparations
- temporary obturation of implant screw access canals
- relining material for prefabricated crowns
- temporary (light cured) cement
- individualization of splints
- forming aids for matrices
- bite registration
FitInspector is an addition-curing silicone for:
- control of precision of fit, marginal adaption and marginal gaps of:
- inlays / onlays;
- crowns and bridges;
- cast metal cores, crowns;
- metal denture bases; and
- provisional cement for inlays, onlays, crowns and bridges
Product codes
EBG, ELW
Device Description
The Provisional Inlay and Onlay materials are light-curing composites.
FitInspector is an addition-curing silicone.
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)
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff; while Composites - Premarket Notification (November 1998).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042820, K020092, K934978, K926418, K931084, K011748, K032289
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
K 052800
2006 MAR !
510(k) Summary
| Trade Name: | Provisional Inlay/Onlay Kit |
|---|---|
| Sponsor: | DMG USA, Inc. |
| 414 South State Street | |
| Dover, DE 19901 | |
| Registration # not yet assigned | |
| Owner/Operator No. 9005969 | |
| Device Generic Name: | Provisional Inlay/Onlay Kit |
Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II.
Predicate Devices:
The proposed Inlay/Onlay kit materials are substantially equivalent to several currently marketed dental restorative materials including the following:
| Product Name | 510(k) # | Manufacturer |
|---|---|---|
| Systemp.C&B Plus | K042820 | Ivoclar Vivadent, Inc. |
| Temphase | K020092 | Kerr Dental |
| Fermit N Lightcuring | ||
| Temporary Filling | ||
| Material | K934978 | Ivoclar North America, Inc. |
| Clip | K926418 | Voco GmbH |
| Tempit | K931084 | Centrix, Inc. |
| First Fill R.C.S. | K011748 | Jeneric/ Pentron, Inc. |
Table J.1: Substantial Equivalence - Provisional Inlay/Onlay
The FitInspector material is substantially equivalent to the following impression material:
Table J. 2: Substantial Equivalence - FitInspector
| Product Name | 510(k) # | Manufacturer |
|---|---|---|
| Fit Checker II | K032289 | GC America, Inc. |
Product Description/Indications for Use:
The Provisional Inlay and Onlay materials are light-curing composites for:
- temporary care of inlay and onlay preparations .
- temporary obturation of implant screw access canals .
- relining material for prefabricated crowns .
1
- temporary (light cured) cement �
- . individualization of splints
- . forming aids for matrices
- . bite registration
FitInspector is an addition-curing silicone for:
- control of precision of fit, marginal adaption and marginal gaps of: .
- . inlays / onlays
- . crowns and bridges
- . cast metal cores, crowns
- . metal denture bases
- provisional cement for inlays, onlays, crowns and bridges .
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff; while Composites - Premarket Notification (November 1998).
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate device, the Provisional Inlay/Onlay Kit has been shown to be safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 7
DMG USA, Incorporated C/O Ms. Pamela Papineau C/O MS. Paincia Faconsultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K052800
K052600
Trade/Device Name: Provisional Inlay/Onlay Kit Regulation Number: 21 CFR 872.3770 Regulation Namber. Enporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG and ELW Dated: February 28, 2006 Received: March 03, 2006
Dear Ms. Papineau:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) predice is substantialy equivalent (for the indications for referenced above and have determined the devices marketed in interstate commerce
use stated in the enclosure) to legally marketed medical or to devices that use stated in the enclosure) to legally that of the Medice Amendments, or to devices that prior to May 28, 1976, the enactment uals of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal PMA). You may. have been reclassified in accordance with the provisions of the Act . Tou may, a Act (Act) that do not require approval of a premated controls provisions of the Act. The general
therefore, market the device, subject to the general controls provisions of therefore, market the device, subject to the general vegistration, listing of devices, good
controls provisions of the Act include requirements for and adulteration controls provisions of the Act metade requirements for and adulteration.
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 If your device is classified (see above) into Chile Crass in (erealations affecting your device can be
may be subject to such additional controls. Title 21 to 200 to 900 to 9 may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to Register found in the Code of I cacra. In the Federal Register.
3
Page 2 - Pamela Papineau, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease be advisod that 127 rination that your device complies with other requirements of the Act or that 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 promated no divice 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,
Susan Runner
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
4
Page of
K052800 510(k) Number (if known):
Device Name: Provisional Inlay/Onlay Kit
Indications for Use:
The provisional inlay and onlay materials are light-curing composites for:
- temporary care of inlay and onlay preparations 트
- temporary obturation of implant screw access canals 트
- 트 relining material for prefabricated crowns
- .. temporary (light cured) cement
- 에 individualization of splints
- 트 forming aids for matrices
- 트 bite registration
FitInspector is an addition-curing silicone for:
- control of precision of fit, marginal adaption and marginal gaps of: 비
- inlays / onlays; -
- crowns and bridges;
- cast metal cores, crowns; -
- metal denture bases; and
- provisional cement for inlays, onlays, crowns and bridges ■
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use X (Part 21 CFR 801 Subpart D) | AND/OR | Over-the -Counter Use (21 CFR 807 Subpart D) |
|---|---|---|
| ------------------------------------------------------- | -------- | ---------------------------------------------- |
Sman Rumse
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Injection Control, Dental Devices
| 510(k) Number | K052800 |
|---|---|
| --------------- | --------- |