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

Device Description

The Provisional Inlay and Onlay materials are light-curing composites. FitInspector is an addition-curing silicone.

AI/ML Overview

This 510(k) summary is for a Provisional Inlay/Onlay Kit and a component called FitInspector. The submission is a request for substantial equivalence based on predicate devices. It does not contain an independent study with new performance data against acceptance criteria. Therefore, most of the requested information cannot be extracted directly from the provided text.

Here is an explanation of why and what can be extracted:

No new performance data or acceptance criteria are presented: The document states, "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)." This means the submission relies on demonstrating that the device is substantially equivalent to already approved predicate devices, rather than presenting new performance data against pre-defined acceptance criteria for the new device.

Therefore, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts used to establish ground truth for the test set and qualifications.
Adjudication method for the test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
Whether a standalone (algorithm only) performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a specific study of this device.
Sample size for the training set.
How the ground truth for the training set was established.

Information that can be extracted:

1. Device and Predicate Devices:

Device Type	Trade Name	510(k) # (for predicates)	Manufacturer
Provisional Inlay/Onlay Kit	Provisional Inlay/Onlay Kit	N/A (this device)	DMG USA, Inc.
Predicate (Inlay/Onlay)	Systemp.C&B Plus	K042820	Ivoclar Vivadent, Inc.
Predicate (Inlay/Onlay)	Temphase	K020092	Kerr Dental
Predicate (Inlay/Onlay)	Fermit N Lightcuring Temporary Filling Material	K934978	Ivoclar North America, Inc.
Predicate (Inlay/Onlay)	Clip	K926418	Voco GmbH
Predicate (Inlay/Onlay)	Tempit	K931084	Centrix, Inc.
Predicate (Inlay/Onlay)	First Fill R.C.S.	K011748	Jeneric/Pentron, Inc.
FitInspector (component)	FitInspector	N/A (this device)	DMG USA, Inc.
Predicate (FitInspector)	Fit Checker II	K032289	GC America, Inc.

2. Type of Study:

Abbreviated 510(k): The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new performance data against pre-defined acceptance criteria. It refers to FDA guidance documents: "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications" and "Guidance for Industry and FDA Staff; while Composites - Premarket Notification (November 1998)."

Conclusion from document:

"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."

Summary

{0}------------------------------------------------

K 052800

2006 MAR !

510(k) Summary

Trade Name:	Provisional Inlay/Onlay Kit
Sponsor:	DMG USA, Inc.414 South State StreetDover, DE 19901Registration # not yet assignedOwner/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 LightcuringTemporary FillingMaterial	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
---------------	---------

Regulation Number and Section

§ 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.