DIMENSION® BITE is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.

DIMENSION® BITE is similar in intended use and substantially equivalent to Roydent's polyvinyl siloxane based impression and bite registration material PANASIL® and ESPE's polyvinyl siloxane based impression material DIMENSION® PENTA.

The composition of the new DIMENSION® BITE contains the same ingredients as ESPE's DIMENSION® PENTA® impression material except one softening agent which is contained in ESPE's polyether based impression material PERMADYNE® GArant®.

AI/ML Overview

This document describes a 510(k) submission for a dental impression material named DIMENSION® BITE. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as would typically be found for AI/software-as-a-medical-device (SaMD).

Therefore, many of the requested categories for a SaMD study are not applicable or cannot be extracted from the provided text. The submission relies on comparing physical and mechanical properties, not an AI algorithm's performance.

Here's the information that can be extracted or derived from the provided text, with explanations where categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (impression material), substantial equivalence is demonstrated by comparing the physical and mechanical properties of the new device to a legally marketed predicate device. While specific quantitative acceptance criteria are not explicitly listed in the provided text (like a specific tensile strength value that must be met), the acceptance criterion is implicitly that the new device's properties are comparable or equivalent to the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Physical and mechanical properties comparable to predicate device.	"The physical and mechanical properties of the new DIMENSION® BITE have been compared to those of the old DIMENSION® BITE (FUTAR® OCCLUSION)."
Same intended use as predicate device.	"DIMENSION® BITE is similar in intended use and substantially equivalent to Roydent's polyvinyl siloxane based impression and bite registration material PANASIL®..."
Safe and effective.	"The above mentioned impression and bite registration materials are well established and considered to be safe and effective."

2. Sample Size Used for the Test Set and the Data Provenance

This information is typically relevant for studies involving data-driven algorithms or diagnostic tests. For a physical material comparison, "test set" in the traditional sense of a dataset for an algorithm is not applicable. The comparison was likely performed on samples of the manufactured material. The text does not provide specific sample sizes for the physical/mechanical property testing or data provenance for these tests (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. "Ground truth" in this context refers to a clinically validated reference standard for an algorithmic decision. For an impression material, the "ground truth" of its properties would be determined by laboratory testing measurements, not expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human annotators or readers in studies where a definitive "ground truth" is established through human interpretation. This is not relevant for an impression material's physical property testing.

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

Not applicable. This is not a study involving human readers or AI assistance. It's a comparison of a physical dental material.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no algorithm involved in this device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" for demonstrating substantial equivalence is based on objective measurements of physical and mechanical properties (e.g., tensile strength, tear strength, dimensional stability, viscosity, working time, setting time) in a laboratory setting, compared to the predicate device. The text itself doesn't detail these specific property measurements, but states they were compared.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" for this device.

Summary

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Kaa locy

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS II.

Submitter

Name:	ESPE Dental AG
Street:	ESPE Platz
ZIP-Code, City:	D-82229 Seefeld
Federal State:	Bavaria
Country:	Germany
Establishment Registration Number:	9611385
Contact:	Dr. Andreas Petermann, Regulatory Affairs
Phone:	011-49-8152-7001395
Fax:	011-49-8152-7001869
E-mail	Andreas_Petermann@ESPE.de

Name of Device

Proprietary Name:	DIMENSION® BITE
Classification Name:	Impression material
Common Name:	Bite registration material

Predicate Devices

PANASIL® by Roydent	K 954281
DIMENSION® PENTA by ESPE	K 960547
PERMADYNE® GARANT® by ESPE	K 953374

Description for the Premarket Notification

DIMENSION® BITE is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.

In recent years ESPE was already marketing a bite registration material tradenamed DIMENSION® BITE in USA. This material is a private label product and

Image /page/0/Picture/13 description: The image shows the logo for 510(k) DIMENSION® BITE. The logo features the text "510(k) DIMENSION® BITE" in a sans-serif font. Below the text is a logo with a tree on the left and the word "ESPE" on the right.

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manufactured by Kettenbach. The same device is marketed in USA under the name FUTAR® OCCLUSION by Roydent. Roydent holds the 510(k) for the material (K 954281). To be independent from suppliers, ESPE decided to develop an own polyvinyl siloxane based bite registration material which will replace the private label material.

The basis for ESPE's new development is the good experience with its addition type silicone based impression material DIMENSION® PENTA.

The physical and mechanical properties of the new DIMENSION® BITE have been compared to those of the old DIMENSION® BITE (FUTAR® OCCLUSION).

The above mentioned impression and bite registration materials are well established and considered to be safe and effective.

Image /page/1/Picture/5 description: The image shows the logo for 510(k) DIMENSION Bite. The logo features a stylized leaf design to the left of the word "ESPE". The text is in a simple, sans-serif font and is arranged in a stacked format.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines forming its body and wings.

JUN 18 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Andreas Petermann Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany

Re: K991008 DIMENSION® BRITE Trade Name: Requlatory Class: II Product Code: ELW Dated: March 24, 1999 March 26, 1999 Received:

Dear Dr. Petermann:

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. ਜ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Requster.

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Page 2 - Dr. Petermann

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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STATEMENT OF INDICATIONS FOR USE III.

. .

Device Name:

DIMENSION® BITE

Indications for use:

Bite registration

Intraoral guide pin excursion tracing

Prescription Use
(Per 21 CFR 801.109)

Susa Rurr

(Division Sign-Off) Division of Dental, Infection Control, Division of Dental, Infecti
and General Hospital Dey
510(k) Number 510(k) Number _

Image /page/4/Picture/9 description: The image shows the logo for 510(k) DIMENSION® BITE. The logo consists of the text "510(k) DIMENSION® BITE" in a sans-serif font. Below the text is the logo for ESPE, which consists of a stylized tree inside of a square, followed by the text "ESPE" in a bold sans-serif font.

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).