Xantropren Comfort is a silicone based condensation curing impression material used for all inlay, crown and bridge, edentulous and partial impressions. The Xantropren Comfort Activator is the catalyst. This product is packaged in a cartridge delivery system which will dispense equal amounts of base and activator.

Device Description

Xantopren Comfort is a is silicone based condensation curing impression material used for all inlay, crown and bridge, edentulous and partial impressions. The advantage of Xantopren Comfort Light and Xantopren Comfort Medium is that the product is available in a cartridge delivery system that ensures that the correct amount of base and catalyst is used each time. With the cartridge delivery system a homogenous mix is obtained each time the material is expressed through the mixing tip. The user cannot manipulate the properties of the product because of the delivery system.

AI/ML Overview

The provided text describes a 510(k) summary for the medical device Xantopren Comfort Base and Activator. It focuses on demonstrating substantial equivalence to a predicate device, CutterSil Light [K760756]. The study described is a clinical handling characteristics evaluation and a comparison of physical properties.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" as clear pass/fail thresholds for each property. Instead, it presents a comparison of the Xantopren Comfort's properties against the predicate device, CutterSil Light. The underlying acceptance criterion for substantial equivalence is that the new device's properties are similar to or within the range of the predicate device for relevant characteristics.

PROPERTIES	Acceptance Criteria (Predicate: CutterSil Light)	Reported Device Performance (Xantopren Comfort Light)	Reported Device Performance (Xantopren Comfort Medium)
Mixing Time (s)	30 (Light), 45 (Medium)	- (Not reported for Xantopren Comfort)	- (Not reported for Xantopren Comfort)
Working Time (min)	2:00 (Light), 2:00 (Medium)	2:00	2:30
Setting Time (min)	4:00 (Light), 4:00 (Medium)	3:00	3:30
Shore A Hardness	- (Not reported for CutterSil Light/Medium)	36	38
Max. Deformation Under Pressure (%)	2-10 (Light and Medium)	8.0	7.5
Recovery From Deformation (%)	97.5 (Light and Medium)	>98	>98
Linear Dimensional Change (%)	-1.0 - 0 (Light and Medium)	1.0	1.0

Note on "Acceptance Criteria" interpretation: For the "Mixing Time", "Shore A Hardness", and "Linear Dimensional Change" for some predicate devices, explicit values are missing or presented differently, making direct "acceptance criteria" from the predicate challenging to define precisely from this text alone. The overall assessment is one of "similarity."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size:
- For the clinical handling characteristics evaluation (dispensing, viscosity, working time, setting time, color differentiation, quality of impression, ease of disinfection): "A minimum of 20 impressions were taken." This refers to clinical use.
- For the physical property comparison, the sample size for individual tests (e.g., Shore A Hardness, Max. Deformation, Recovery, Dimensional Change) is not specified.
Data Provenance: Not specified in the document. It does not mention country of origin or if it was retrospective or prospective. It is implied to be prospective data collection given the nature of a 510(k) submission for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document implies evaluation by dentists or dental professionals during the clinical handling characteristics evaluation, stating "The injection tips on the cartridge delivery system can be angled to suit the needs to the dentist." However, the number of experts and their specific qualifications are not explicitly stated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

None described. The text does not detail any formal adjudication method for the clinical observations or property measurements. The findings presented are reported as observations ("flowed well," "determined to be adequate," "received an excellent rating").

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms where human interpretation is involved. The device in this submission is an impression material, and the evaluation focuses on its physical and handling properties.

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

Not applicable. This submission is for an impression material, not an algorithm. The "standalone" evaluation refers to the physical and handling characteristics of the material itself. The physical properties listed in the tables (e.g., Shore A Hardness, Recovery from Deformation) represent standalone performance of the material.

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

For physical properties: The ground truth is established by standard laboratory testing methods for dental impression materials (e.g., ISO standards for measuring working time, setting time, hardness, deformation, dimensional change).
For clinical handling characteristics: The ground truth is based on practical observations and qualitative assessments by dental professionals ("good," "adequate," "excellent rating"). This could be considered a form of expert consensus on handling characteristics.

8. The sample size for the training set

Not applicable. This device is an impression material, not a machine learning model, so there is no training set in the AI sense.

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

Not applicable. As there is no training set, this question is not relevant to this submission.

Summary

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K991425

JUN 1 5 1999

510(K) Summary

June 7, 1999 Date:

Heraeus Kulzer, Inc. Address: 4315 S. Lafayette Blvd. South Bend, IN.

Cheryl V. Zimmerman Contact: 219-299-6662
Xantopren Comfort Base Device: Xantopren Activator

Substantially Equivalent to:

CutterSil Light [K760756] KAI0165 CutterSil Mucosa CutterSil Universal Hardener (Paste & Liquid) [K760756]

Device Description:

An evaluation of the clinical handling characteristics was evaluated for:

dispensing of material(s) ●
viscosity for application .
working time .
setting time
color differentiation e
quality of impression .
ease of disinfection. .

The putty material was used in conjunction with the low viscosity and the medium viscosity Xantopren. A minimum of 20 impressions were taken. Dispensing of the putty material is easily accomplished. One measuring scoop provides adequate material for either a bite or quadrant impression tray. Two measuring scoops are sufficient for a full

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arch impression tray. After bleeding the cartridge, the low and medium Xantopren visciosities flowed well and were easily extruded through the mixing tip with no difficulty. The low and medium viscosity Xantopren were determined to be quite good for impressions. Both viscoisties flow well around the tooth preparation and into the sulcus. The working time and setting time was determined to be adequate, within the ranges stated in the instructions and similar to comparable impression materials. Color differentiation between the low and medium viscosities and the putty's received an excellent rating. The quality of the impression is very good. And both Xantopren Light and Medium bond well to currently marketed products CutterSil Putty Plus and CutterSil Comfort.

The injection tips on the cartridge delivery system can be angled to suit the needs to the dentist. Pouring of the impression is compatible with silicone products (condensation or addition) that are currently in the market place. Ease of disinfection is consistent with similar materials, and no distortion was observed after disinfection.

PROPERTIES	Xantopren Comfort Light	CutterSil Light
Mixing Time (s)	-	30
Working Time (min)	2:00	2:00
Setting Time (min)	3:00	4:00
Shore A Hardness	36	-
Max. Deformation Under Pressure (%)	8.0	2-10
Recovery From Deformation (%)	>98	97.5
Linear Dimensional Change (%)	1.0	-1.0 - 0

Product Comparison:

PROPERTIES	Xantopren Comfort Medium	CutterSil Medium
Mixing Time	-	45
Working Time	2:30	2:00
Setting Time	3:30	4:00
Shore A Hardness	38	-
Max. Deformation Under Pressure	7.5	2-10%
Recovery From Deformation	>98	97.5
Linear Dimensional Change	1.0	-1.0 -0

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 1999

Ms. Cheryl V. Zimmerman Quality Operations and Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517

Re: K991425 Xantopen® Comfort Trade Name: Requlatory Class: II Product Code: ELW Dated: April 21, 1999 Received: April 23, 1999

Dear Ms. Zimmerman:

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 Existing major be subject to such additional controls. requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Ms. Zimmerman

this response to your premarket notification Please note: submission does not affect 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" (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

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Page 1 of 1

510(k) Number (if Known):

Device Name: Xantropren Comfort Base Paste and Activator

Indications For Use:

(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

	Susan Runver	(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,and General Hospital Devices
510(k) Number	1911925

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).