Taking impression over fixed/removable restorations and implants -(transferring impression posts and bridge components)
-Fuctional impresssions.
Fabricating crown and bridgework or inlays. .
Fabricating full or partical dentures. .
Reline impressions. י
Use in the simultaneous mixing technique as well as the putty -
Trnasferring root posts when fabricating posts and cores indirectly. .

Suflex Light is to be used as panaasil contact material for;

Two step putty impressiontechnique. ।
One step putty impression technique. ।
One step impression technique using a foil(plastic putty spacer) l
One step impression technique(simultaneous technique)using dual viscosities. .
-Reline impressions.
Fabricating full or partial dentures. -

Device Description

Suflex Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Suflex Impression Material family consists of four different viscosities(putty, heavy, mono, light), available in an assortment of delivery systems: traditional 1:1 50ml, automix cartridge, 5:1 362ml foil bags for use in most automatic dispensing and mixing systems, and traditional 1:1 putty jars.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Suflex Impression Materials":

Important Note: The provided document is a 510(k) summary for a medical device (dental impression material). These summaries typically don't contain detailed statistical analyses, sample sizes for specific performance metrics, or information about complex AI/ML study designs (like MRMC studies) because the device itself is a material, not a software algorithm. The focus of this submission is on demonstrating substantial equivalence to predicate devices through material properties and biocompatibility.

Acceptance Criteria and Reported Device Performance for Suflex Impression Materials

This submission describes Suflex Impression Materials, which are addition-curing, elastomeric materials for dental impressions. The acceptance criteria and performance are established through bench testing of physical properties and biocompatibility, primarily by demonstrating equivalence to predicate devices or compliance with ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric (Reference)	Reported Device Performance	Comments
Biocompatibility
Cytotoxicity (ISO 10993-5)	Comparable to other materials on the market	Biological safety assured
Sensitization (ISO 10993-10)	Comparable to other materials on the market	Biological safety assured
Mucosa Irritation (ISO 10993-10)	Comparable to other materials on the market	Biological safety assured
Chemical Analysis	Biocompatibility data comparable to other materials on the market
Mechanical Properties (Bench Testing)		Evaluation in comparison to already marketed products
Component colors (ISO 4823, 6.1)	Results indicate adequate consistency	Compared to leading impression materials
Working time (ISO 4823, 6.3)	Results indicate adequate consistency	Compared to leading impression materials
Compatibility with gypsum (ISO 4823, 6.4)	Results indicate adequate consistency	Compared to leading impression materials
Consistency (ISO 4823, 6.4)	Results indicate adequate consistency	Compared to leading impression materials
Detail reproduction (ISO 4823, 6.4)	Results indicate adequate consistency	Compared to leading impression materials
Linear dimensional change (ISO 4823, 6.4)	Results indicate adequate consistency	Compared to leading impression materials
Elastic recovery (ISO 4823, 6.4)	Results indicate adequate consistency	Compared to leading impression materials
Strain-in-compression (ISO 4823, 6.4)	Results indicate adequate consistency	Compared to leading impression materials

Summary of Device Performance: The Suflex Impression Materials demonstrated adequate consistency in their mechanical properties when compared to leading impression materials already on the market, based on ISO 4823 test methods. Furthermore, biocompatibility testing (cytotoxicity, sensitization, mucosa irritation, and chemical analysis) showed comparable data to other marketed materials, assuring biological safety in accordance with the ISO 10993 family of standards.

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

Sample Size: The document does not specify the exact sample sizes used for the mechanical property bench tests or biocompatibility tests. It broadly states that "bench testing was performed" and "biocompatibility tests have been performed."
Data Provenance: The tests were conducted to support a submission by Osstem Germany GmbH. While the exact location of the testing is not specified, it's likely that the tests were performed by the manufacturer or a third-party laboratory. The data would be retrospective in nature, generated specifically for this premarket submission. No information on country of origin of the data is provided beyond the submitting company's location (Germany) and correspondent's location (USA).

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

Number of Experts: This information is not provided in the document.
Qualifications of Experts: This information is not provided in the document.

Given that this is a material science study focusing on physical properties and biocompatibility, "experts" in the traditional clinical sense (like radiologists) are not typically involved in establishing ground truth for such bench tests. The "ground truth" is typically defined by the test methods themselves (e.g., ISO standards), with results verified by qualified laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method like 2+1 or 3+1. This is expected as the evaluation relies on objective, standardized physical and chemical tests rather than subjective human interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for medical imaging AI algorithms where human readers (e.g., radiologists) interpret images with and without AI assistance. This device is an impression material, not an AI or imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study of an algorithm was done. This device is an impression material, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily based on:

International Standards: Specifically, the ISO 10993 family for biocompatibility and ISO 4823 for impression materials mechanical properties. These standards define the methodologies and expected ranges for various material characteristics.
Comparison to Predicate Devices: The "comparable to other materials on the market" and "compared to leading Impression materials" statements indicate that the performance of legally marketed predicate devices serves as a practical "ground truth" or benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is a physical material, not a machine learning model. Therefore, there is no "training set." The testing performed relates to material properties.

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

Not applicable. As there is no training set for a machine learning model, this question does not apply to this device.

Summary

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K133527

MAR - 7 2014

Image /page/0/Picture/2 description: The image shows the word "OSSTEM" in bold, black letters. Below the word "OSSTEM" is the word "IMPLANT" in smaller, thinner, black letters. There is a degree symbol to the right of the word "OSSTEM". The background is white.

Osstem Germany GmbH

#Mergenthaler Allee 25, 65760 Eschborn, Germany Tel. +49(0)6196 777 550 · Fax. +49 (0}6196 777 55 06 www.osstem.de, www.sinuskit.com

Osstem Germany GmbH.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Jessica Jung

+49 6196 777 550

HIOSSEN Inc.

Patrick Lim

ELW

888 678 0001

Date: July 12, 2013

Company and Correspondent making the submission:

Submitter's Name :
Address
Contact :
Phone:
Correspondent's Name:
Address:
Contact:
Phone:

Device :

Trade or (Proprietary) Name :

Common or usual name :

Classification Name :

Suflex Impression Materials to include: Suflex putty Suflex Heavy Suflex Mono Suflex Light Impression material Material, Impression(21 CFR 872.3660.Product) 21CFR872.3640 Class II

85 Ben Fairless Dr. Fairless Hills, PA 19030

#Mergenthaler Allee 25, 65760 Eschborn, Germany

Predicate Device: Trade Name: Trade Name: Trade Name:

Trade Name:

Panasil Impression Materials(K082560) Panasil Impression Materials(K954282) Aquasil Ultra Rigid Smart Wetting Impression Material (K021413) Aquasil Ultra XLV Smart Wetting Impression Material (K021410) Kerr VPS Impression Material(K050604)

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Image /page/1/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in black and is a stylized font. The word "OSSTEM" is on the top line and the word "IMPLANT" is on the bottom line.

Osstem Germany GmbH.

#Mergenthaler Allec 25, 65760 Eschborn, Germany Tel. +49(0)6196 777 550 · Fax. +49 (0)6196 777 55 06 www.osstem.de. www.sinuskit.com

4. Description:

5. Intended use

be placed on an impression tray(or infected directly into the mouth, depending on the technique and device)and used to reproduce the structure of a patient's teeth and gums.
provide models for study and for production of restorative prosthetic devices.

6. Indication for use

Suflex Putty is to be used as panasil putty material for;

Two step putty impression technique l
One step putty impression technique
Two step putty impression technique using a foil(plastic putty spacer) .
One step putty impression technique for forming functional peripheries. -

Suflex Heavy is to be used a s panasil tray material for;

One step impressiontechnique using sinte or dual viscosities. ।
Two step impression technique using dual viscosities ।
Functional impressions. -

Suflex Mono is to be used as panasil monophase material for;

Taking impression over fixed/removable restorations and implants -(transferring impression posts and bridge components)
-Fuctional impresssions.
Fabricating crown and bridgework or inlays. .
Fabricating full or partical dentures. .
Reline impressions. י
Use in the simultaneous mixing technique as well as the putty -
Trnasferring root posts when fabricating posts and cores indirectly. .

Suflex Light is to be used as panaasil contact material for;

Two step putty impressiontechnique. ।
One step putty impression technique. ।
One step impression technique using a foil(plastic putty spacer) l
One step impression technique(simultaneous technique)using dual viscosities. .
-Reline impressions.
Fabricating full or partial dentures. -

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Image /page/2/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is written in a bold, sans-serif font, with the word "IMPLANT" written in a smaller font below it. There is a degree symbol to the right of the word "OSSTEM".

Osstem Germany GmbH.

#Mergenthaler Allee 25, 65760 Eschborn, Germany Tel. +49(0)6196 777 550 - Fax. +49 (0)6196 777 55 06 www.osstem.de, www.sinuskit.com

7. Summary of Non-Clinical Performance Testing

Biocompatibility tests have been performed to assure biological safety in accordance with the ISO 10993 family. Tests in respect to cytotoxicity(ISO 10993-5), sensitization and mucosa irritation(ISO 10993-10) and a chemical analysis showed, that Suflex materials' biocompatibility data is comparable to other materials on the market. Additionally bench testing was performed to allow an evaluation of the mechanical properties of Sulex in comparison to already marketed products. The evaluation covers

Component colours (ISO 4823, 6.1)

Working time (ISO 4823, 6.3)
| Compatibility with gypsum (ISO 4823, 6.4)
Consistency(ISO 4823, 6.4)
Detail reproduction(ISO 4823, 6.4)
Linear dimensional change(ISO 4823, 6.4)
Elastic recovery(ISO 4823, 6.4)
Strain-in-compression(ISO 4823, 6.4)

The results indicate adequate consistency results compared to leading Impression materials.

8. Summarv of clinical testing

No clinical studies are submitted

9. Conclusions

Osstem Germany GmbH believes that the Suflex Impression material is substantially equivalent to the currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2014

Osstem Germany GmbH C/O Mr. Patrick Lim QA/RA Manager HIOSSEN, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030

Re: K133527

Trade/Device Name: Suflex Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: November 27, 2013 Received: December 11, 2013

Dear Mr. Lim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicaiDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/7 description: The image shows the name "Erin F. Keith-S" in a stylized font. The name is written in black ink and is easily readable. The letters are bold and have a slightly rounded appearance. The overall impression is that of a professional and well-designed logo or nameplate.

Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image contains the logo for OSSTEM IMPLANT. The word "OSSTEM" is in a bold, sans-serif font, with the letters slightly overlapping each other. The word "IMPLANT" is in a smaller, sans-serif font and is located directly below "OSSTEM". There is a degree symbol to the right of the word "OSSTEM".

Osstem Germany GmbH.

#Mergenthaler Allec 25, 65760 Eschborn, Germany Tel. +49(0)6196 777 550 - Fax. +49 (0)6196 777 55 06 www.osstem.de. www.sinuskit.com

510(k) Number K _133527

Device Name : Suflex impression materials

Indication for use :

Suflex Putty is to be used as panasil putty material for;

Two step putty impression technique 。
One step putty impression technique -
Two step putty impression technique using a foil(plastic putty spacer) l
One step putty impression technique for forming functional peripheries. .

Suflex Heavy is to be used a s panasil tray material for;

One step impression technique using single or dual viscosities. ,
Two step impression technique using dual viscosities .
Functional impressions. -

Suflex Mono is to be used as panasil monophase material for;

Taking impression over fixed/removable restorations and implants . (transferring impression posts and bridge components)
Functional impressions. .
-Fabricating crown and bridgework or inlays.
Fabricating full or partial dentures. 1
Reline impressions. ।
Use in the simultaneous mixing technique as well as the putty .
Transferring root posts when fabricating posts and cores indirectly. -

Suflex Light is to be used as panasil contact material for;

Two step putty impression technique. .
One step putty impression technique. -
One step impression technique using a foil(plastic putty spacer) -
One step impression technique (simultaneous technique) using dual viscosities. -
Reline impressions. -
Fabricating full or partial dentures. .

Prescription Use X (Per 21CFR801 Subpart D)

Over-The-Counter Use OR (Per 21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner -5
FDA 2024.09.06
07:56:58-05'00'

1 / 1

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).