PermaCem: PermaCem is a chemical-curing, radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other.

PermaCem Dual: PermaCem Dual is a dual cure (chemical and/or light cure), radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the PermaCem and PermaCem Dual dental luting materials. It is an "Abbreviated 510(k)" which relies on compliance with recognized FDA guidance documents and international standards rather than extensive de novo studies. Therefore, much of the requested information regarding a specific device performance study and acceptance criteria in the traditional sense is not directly provided in this submission summary.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the submission is an "Abbreviated 510(k)" demonstrating conformity with:

FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998
ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.

Therefore, the acceptance criteria are implicitly the performance requirements specified within these standards and guidance documents for dental luting materials. The "reported device performance" is the claim by the sponsor that the devices conform to these criteria, which then supports the claim of substantial equivalence.

Since specific quantitative acceptance criteria or direct performance results (e.g., bond strength values, setting times) are not explicitly listed in the provided text, a table cannot be fully populated from this document. However, the nature of the submission (Abbreviated 510(k)) indicates that the device's performance meets the standard requirements from ISO 4049 and FDA guidance for similar devices.

2. Sample size used for the test set and the data provenance

Sample size: Not specified in the provided text.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies referenced would be those conducted to demonstrate compliance with ISO 4049 and FDA guidance, but details are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. An Abbreviated 510(k) for a dental luting material would typically involve laboratory testing against established physical and chemical properties, not human interpretation of data requiring "ground truth" derived from experts in the clinical sense.

4. Adjudication method for the test set

Not applicable and not provided. The compliance would be based on objective laboratory measurements against set standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to an Abbreviated 510(k) for a dental luting material. This type of study is relevant for diagnostic imaging AI devices, not for dental cements.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a dental luting material, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this type of device would be the established physical and chemical properties required by ISO 4049 and FDA guidance for dental cements, such as bond strength, setting time, solubility, radiopacity, and biocompatibility. This "ground truth" is determined through laboratory testing methods outlined in the standards, not expert consensus or pathology in a diagnostic sense.

8. The sample size for the training set

Not applicable. This device is a dental luting material, not an AI system that requires training data.

9. How the ground truth for the training set was established

Not applicable. This device is a dental luting material, not an AI system.

Summary

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

Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K012316' and are written in a bold, sans-serif style. The characters are all connected and are written in black ink.

AUG 2 3 2001

Trade Name:	PermaCem / PermaCem Dual
Sponsor:	DMG USA, Inc.414 South State StreetDover, DE 19901
	Registration # not yet assigned
Device Generic Name:	Dental luting material
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.

Predicate Devices:

Product Name	510(k) #	Manufacturer
Advance	K 940914	Dentsply Int'l.
Optibond	K940513	Kerr Mfg. Co.
C&B Luting Composite	K940030	Bisco
Flexi-Flow	K922249	EDS
C&B Metabond	K960464	Parkell
Duolink	K943596	Bisco
Variolink	K931309	Vivadent
Dyract Cem	Unknown	Dentsply
Fuji Duet (Fuji Plus)	K946100	GC
Resinomer	K924151	Bisco
Cement-It	Unknown	Jeneric/Pentron Inc.
ABC Dual Adhesive Bridge Cement	Unknown	Vivadent

510(k) Summary

Product Description:

PermaCem:

PermaCem is a chemical-curing, radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other. Possible uses include:

. Luting of orthodontic anchors and brackets
. Luting of abutments to dentures
. Core build-up material
Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials .
. Repair material for provisionals
. Bite registration material
. Build up material for plastic bite rails (occlusal individualisation).

PermaCem Dual:

PermaCem Dual is a dual cure (chemical and/or light cure), radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of

{1}------------------------------------------------

metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other. Possible uses include:

Core build-up material .
Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials .
Repair material for provisionals .
Bite registration material ●
Build up material for plastic bite rails (occlusal individualisation). .

Indications for Use:

PermaCem is a chemical cure compomer cement for permanent luting of metal, resin or ceramic crowns, bridges, inlays and onlays.

PermaCem Dual is a dual cure compomer cement for permanent luting of metal, resin or ceramic crowns, bridges, inlays and onlays.

PermaCem and PermaCem Dual can also be used for:

. Luting of orthodontic anchors and brackets
Luting of abutments for dentures .
Core build-up
Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
Repair material for resin-based provisionals
. Bite registration material
. Occlusal individualisation of plastic bite rails

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, Inc. has provided information to demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998 and ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.

Conclusion:

Based on their indications for use, technological characteristics, and comparison to predicate devices, the PermaCem / PermaCem Dual materials have been shown to be safe and effective for their intended use.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or stripes, which are meant to represent a stylized caduceus, a symbol often associated with healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2001

Ms. Pamela Papineau Consultant DMG USA, Incorporated 414 South State Street Dover, Delaware 19901

Re : K012316 Trade/Device Name: Permacem/Permacem Dual Requlation Number: 872.3275 Regulatory Class: II Product Code: EMA Dated: June 22, 2001 Received: July 23, 2001

Dear Ms. Papineau:

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 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). 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 (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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

{3}------------------------------------------------

Page 2 - Ms. Papineau

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ente feed any obligation you might have under sections 531 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

A. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

DMG USA Inc. Abbreviated 510(k) Premarket Notification

K012316

0000

PermaCem / PermaCem |

Page 1

510(k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Device Name: PermaCem / PermaCem Dual

Indications for Use:

PermaCem is a chemical cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays.

PermaCem Dual is a dual cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays.

PermaCem Dual can also be used for:

Luting of orthodontic anchors and brackets .
Luting of abutments for dentures ●
Core build-up .
Splinting of teeth in combination with wires, Kevlar or Ribbond-type . materials
Repair material for resin-based provisionals .
. Bite registration material
Occlusal individualisation of plastic bite rails .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __
(Per 21 CFR 801.109)

OR Over-the Counter Use __

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number __ K012316

Regulation Number and Section

§ 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.