PROVISIONAL INLAY/ONLAY KIT

K052800 · Dmg USA, Inc. · EBG · Mar 7, 2006 · Dental

Device Facts

• Record ID: K052800
• Device Name: PROVISIONAL INLAY/ONLAY KIT
• Applicant: Dmg USA, Inc.
• Product Code: EBG · Dental
• Decision Date: Mar 7, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended 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 - provisional cement for inlays, onlays, crowns and bridges .

Device Story

Provisional Inlay/Onlay Kit comprises light-curing composite materials and FitInspector addition-curing silicone. Used by dental professionals in clinical settings for temporary restorations, cementation, and prosthetic fit assessment. Composite materials applied to inlay/onlay preparations, implant access canals, or as relining/forming aids; light-cured to achieve temporary structure. FitInspector silicone applied to prosthetics (crowns, bridges, inlays/onlays, metal cores, denture bases) to evaluate marginal adaptation and fit precision. Output is physical temporary restoration or visual/tactile assessment of prosthetic fit. Benefits include temporary protection of dental preparations and verification of prosthetic accuracy prior to final cementation.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence demonstrated through comparison of technological characteristics and adherence to FDA guidance for dental composites.

Technological Characteristics

Provisional materials: light-curing composites. FitInspector: addition-curing silicone. Form factor: kit-based dental materials. Energy source: external light-curing unit for composites. Sterilization: not specified (standard dental material handling).

Indications for Use

Indicated for dental patients requiring temporary restorative care, including inlay/onlay preparations, implant screw access canal obturation, prefabricated crown relining, splint individualization, matrix forming, bite registration, and fit assessment of dental prosthetics.

Regulatory Classification

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.

Predicate Devices

• Systemp.C&B Plus (K042820)
• Temphase (K020092)
• Fermit N Lightcuring Temporary Filling Material (K934978)
• Clip (K926418)
• Tempit (K931084)
• First Fill R.C.S. (K011748)
• Fit Checker II (K032289)

Submission Summary (Full Text)

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K 052800

2006 MAR !

# 510(k) Summary

| Trade Name: | Provisional Inlay/Onlay Kit |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | DMG USA, Inc.<br>414 South State Street<br>Dover, DE 19901<br>Registration # not yet assigned<br>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<br>Temporary Filling<br>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 .

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- 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.

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## 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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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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 <b>X</b> (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 |
|---------------|---------|
|---------------|---------|