Chemi-SiL of silicone impression materials are hydrophilic impression materials based on polyvinylsiloxane and it is used for impression of teeth or gingiva. It consists of three different consistencies (heavy body, light body, bite registration material) according to ISO 4823. And it is supplied base and catalyst in contrasting color. Each product is consisted of 1:1 base and catalyst component, packaged in two 50 mL catridges.

AI/ML Overview

This document is a 510(k) Premarket Notification from B&E Korea Co., Ltd. for their dental impression materials, Chemi-SiL (HB, MB, LB, LBS) and Chemi-SiL Bite-Blu. The key focus of this notification is to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The primary method for demonstrating acceptance criteria and performance is through non-clinical testing based on recognized international standards, specifically ISO 4823 for impression materials and ISO 10993 for biocompatibility. The acceptance criteria are the performance requirements specified by these standards and the reported values of the predicate devices. The device performance is the measured performance of the Chemi-SiL products.

Here's a table summarizing the acceptance criteria (defined by ISO standards and predicate device performance) and the reported device performance for Chemi-SiL. Note that the document compares the subject devices to two different predicate devices based on their specific uses.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (ISO Standard / Predicate Device)	Reported Device Performance (Chemi-SiL)	Discussion/Justification (from document)
For Chemi-SiL (HB, MB, LB, LBS) vs. Vonflex STM (K152615)
Working time	Vonflex STM: 2'15" (Heavy, normal); 1'30" (Heavy, Fast); 2'30" (Light, normal); 1'30" (Light, Fast) [ISO 4823:2021 7.3] suggested value of the manufacturer	Chemi-SiL: MB: 90 s; HB: (No explicit value given, implied to be comparable to "Fast"); LB: 90 s; LBS: (No explicit value given, implied to be comparable to "Fast")	Equivalent
Setting reaction time	Vonflex STM: 4'00" (Heavy, normal); 2'30" (Heavy, Fast); 4'00" (Light, normal); 2'30" (Light, Fast)	Chemi-SiL: MB: 210 s; HB: (N/A, implied to be comparable to "Fast"); LB: 210 s; LBS: (N/A, implied to be comparable to "Fast")	Equivalent
Consistency	Vonflex STM: 34.76 mm (Heavy, normal); 34.78 mm (Heavy, Fast); 43.43 mm (Light, normal); 42.02 mm (Light, Fast) [ISO 4823:2021 7.2] <= 35 mm (Heavy), >= 36 mm (Light)	Chemi-SiL: MB: 32.75 mm; HB: (N/A); LB: 48.83 mm; LBS: (N/A)	Equivalent. All values meet the ISO criteria.
Compatibility with gypsum	Vonflex STM: Reproduced for 0.05 mm [ISO 4823:2021 7.6] 50 µm should be reproduced without interruption.	Chemi-SiL: Reproduced for 0.05 mm	Equivalent. Both conform to the standard.
Strain in compression	Vonflex STM: 2.56 % (Heavy, normal); 2.38 % (Heavy, Fast); 7.71 % (Light, normal); 5.24 % (Light, Fast) [ISO 4823:2021 7.8] 0.8~~20 % (Heavy), 2.0~~20 % (Light)	Chemi-SiL: MB: 1.2 %; HB: (N/A); LB: 3.1 %; LBS: (N/A)	Similar. Both conform to the standard. Chemi-SiL values fall within or are superior to the predicate and standard ranges.
Linear Dimensional Change	Vonflex STM: 0.11 % (Heavy, normal); 0.07 % (Heavy, Fast); 0.08 % (Light, normal); 0.09 % (Light, Fast) [ISO 4823:2021 7.5] <= 1.5 %	Chemi-SiL: MB: 0.12 %; HB: (N/A); LB: 0.04 %; LBS: (N/A)	Similar. Both conform to the standard. Chemi-SiL values fall within or are superior to the predicate and standard ranges.
For Chemi-SiL Bite-Blu vs. Hysil Impression Materials HySil Bite (K170736)
Colours	Pass (Predicate)	Pass	Same. The classification of the subject and predicate device is complied with DIN 13903.
Working time	Pass (Predicate)	55 s
Minimum period spent in the mouth	1 min. 30 sec (Predicate)	95 s
Recovery after Deformation	More than 0.1 mm (Predicate)	0.0 mm
Load endurance during bending (Flexural strength)	Pass (Predicate)	8.2 N (20 s)
Hardness degree (HD)	50 HD (Predicate)	50 HD	Same
Linear dimensional change	-0.16 % (Predicate)	0.3 %

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

The document describes non-clinical testing based on referenced standards (ISO 4823, ISO 7405, ISO 10993). This implies laboratory-based, controlled experiments rather than a "test set" of patient data in the typical sense of AI/ML models.

Sample Size: The specific sample sizes for each physical property test are not explicitly stated (e.g., number of specimens tested for consistency). However, compliance with ISO standards usually implicitly requires a minimum number of samples for statistically valid results.
Data Provenance: The data is generated from prospective laboratory testing of the new device (Chemi-SiL HB, MB, LB, LBS, and Bite-Blu) and compared against reference properties of the predicate devices and the requirements of international standards. The country of origin for the testing itself is not explicitly stated, but the manufacturer is B&E KOREA Co., Ltd. (SOUTH KOREA). The data is not retrospective patient data.

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

This type of testing (ISO standard compliance for physical and biocompatibility properties of impression materials) does not involve experts establishing "ground truth" through interpretation of cases like in medical imaging AI. The "ground truth" or "reference" is derived from:

The defined physical property metrics and their acceptable ranges as specified in ISO 4823 (e.g., consistency in mm, strain in compression as a percentage).
The biocompatibility criteria defined by ISO 10993 (e.g., absence of cytotoxicity).
The performance characteristics of the legally marketed predicate devices, which are assumed to meet regulatory and performance requirements.

Therefore, the concept of qualified experts adjudicating a test set is not applicable here.

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

As explained above, this concerns material properties and biocompatibility, not diagnostic or clinical interpretation. Therefore, no adjudication method (like 2+1 or 3+1) was used for establishing ground truth for a test set. The results are obtained directly from standardized laboratory measurements.

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 MRMC comparative effectiveness study was done or is relevant here. This document is for a dental impression material, not an AI or imaging diagnostic device. The study proves the physical and biological characteristics of the material, not the performance of human readers assisted by AI.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance here refers to the intrinsic physical and chemical properties of the material itself.

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

The "ground truth" for this device's performance is established by:

International standards (ISO 4823, ISO 10993, DIN 13903): These standards define the acceptable range or threshold for various physical, chemical, and biological properties.
Performance data of legally marketed predicate devices: The tested characteristics are compared directly to those of the predicate devices, which are deemed safe and effective.

This is a bench testing/laboratory data type of ground truth, not one derived from clinical outcomes, pathology, or expert consensus on patient cases.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a "training set." The materials are developed and characterized through traditional chemical and material science processes, not machine learning.

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

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 13, 2024

B&E Korea Co., Ltd. Jayong Shin RA Representative 995-16. Baran-ro. Jeongnam-myeon Hwaseong-si, Gyeonggi-do 18515 SOUTH KOREA

Re: K233954

Trade/Device Name: Chemi-SiL (HB, MB, LB, LBS) and Chemi-SiL Bite-Blu Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: December 15, 2023 Received: December 15, 2023

Dear Jayong Shin:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

Submission Number (if known)

K233954

Device Name

Chemi-SiL (HB, MB, LB, LBS) Chemi-SiL Bite-Blu

Indications for Use (Describe)

Chemi-SiL (HB, MB, LB, LBS) - Crown and bridge impression, inlay and onlay impressions

Chemi-SiL Bite-Blu

Impression of the occlusal surface
Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

K233954 510(k) SUMMARY

Date: Dec 15, 2023

1. SUBMITTER

B&E KOREA Co., Ltd. 995-16, Baran-ro, Jeongnam-myeon, Hwaseong-si, Gyeonggi-do, Republic of Korea TEL : +82-31-8077-2364 FAX : +82-31-8077-2365 Contact Name: Shin Jayong Email: jayong@bnekorea.com

2. DEVICE

·Trade Name: Chemi-SiL (HB, MB, LB, LBS), Chemi-SiL Bite-Blu

·Common Name: Impression Material

·Classification Name: Material, Impression

·Regulation Number: 872.3660

·Class: 2

·Classification Product Code: ELW

3. PREDICATE DEVICE

Chemi-SiL (HB, MB, LB, LBS) Vonflex STM, K152615

Vericom Co. Ltd

Chemi-SiL Bite-Blu

K170736 Hysil Impression Materials HySil Bite, OSSTEM Implant Co., Ltd.

{5}------------------------------------------------

4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

Chemi-SiL (HB, MB, LB, LBS)

· Crown and bridge impression, inlay and onlay impressions
Chemi-SiL Bite-Blu
Impression of the occlusal surface

6. NON-CLINICAL TESTING

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

ISO 4823 Appearance and Component colors, Consistency, Working time, Detail reproduction, Setting time, Compatibility with gypsum, Linear dimensional change, Elastic recovery, Strain in compression
ISO 7405 Cytotoxicity .
ISO 10993-10 - Skin sensitization, Oral mucosa irritation
ISO 10993-11 - Acute systemic toxicity

7. SUBSTANITAL EQUIVALENCE

Subject device	Predicate Device	Discuss/Justify the Differences

510(k) Number	New	K152615	-
Trade Name	Chemi-SiL (HB, MB, LB,LBS)	Vonflex STM	-
Manufacturer	B&E KOREA Co., Ltd.	Vericom Co. Ltd	-
Common Name	Impression material	Impression material	Same
Device Class	2	2	Same
Product Code	ELW	ELW	Same
Indications for use	• Crown and bridgeimpression, inlay and onlayimpressions	• Impression material in dualphase impression technique• Precise duplication of models• Capturing multiple unitimpressions• Impression of inlay, crown,bridge and partial denture etc.	SameThe subject andpredicate devicehave the sameintended use. Bothdevices are used fordental impressiontechniques accordingto their consistencies.
Physical State	Two product lines are providedwith different viscosity. (Heavybody, Light body)	Various pastes with variousviscosity	SimilarBoth subject andpredicate devices areprovided as puttieswith variouselasticities.The physical statesare similar, ascompared in physicalproperties.
Structure	Addition type silicone basedelastomeric impressionmaterials	Addition type silicone basedelastomeric impressionmaterials	Same
Packaging	Primary packaging: CartridgesSecondary packaging: Cartonbox	Primary packaging: CartridgesSecondary packaging: Cartonbox	Same
Usage	Single patient, single use.Not reusable	Single patient, single use.Not reusable	Same
Sterility	Non-sterile	Non-sterile	Same
Handling System	Two part base/catalyst system	Two part base/catalyst system	Same
Type of Curing	Self-curing after mixing of base and catalyst part.	Self-curing after mixing of base and catalyst part.	Same
Physical properties	See the table below	See the table below	SimilarIndividual values ofphysical propertiesare same or similar.Every physicalproperty of predicateand subject deviceconforms to therelated standard.
Chemical composition	Poly(dimethylsiloxane), vinylterminatedSiloxanes and Silicones, di-ME,ME Hydrogen, Hydrogen-terminated Methyl hydrogenpolysiloxanesSynthetic amorphous SilicaHydrophilic Fumed SilicaPlatinum complex(3 % Pt by weight)Pigmentssurfactant	Vinyl siloxanesHydrogen polysiloxaneSilicaFumed silicaOrgano platinum complexPigmentsSurfactant	SimilarBoth device arecomposed of vinylterminated siloxane,cross-linkingsiloxane, Filler,platinum catalyst,pigments andsurfactant.
Biocompatibility	Meets ISO 10993-1 for asurface device contactingmucosal membrane and dentinfor a short-term contactduration (>24h)	Conforms with ISO 10993-1	Same
Standards conformed	ISO 4823ISO 10993-1	ISO 4823ISO 10993-1	Same

{6}------------------------------------------------

{7}------------------------------------------------

Physical properties

-	Chemi-SiL (HB, MB, LB, LBS)	Vonflex STM	Standard	Discuss/Justify the

					Differences
Working time	MB	90 s	2'15"(Heavy,normal)	[ISO4823:20217.3]suggestedvalue of themanufacturer	Equivalent
	HB		1'30"(Heavy,Fast)
	LB	90 s	2'30"(Light,normal)		Equivalent
	LBS		1'30"(Light,Fast)
Setting reaction time	MB	210 s	4'00" (Heavy,normal)	-	Equivalent
	HB		2'30" (Heavy,Fast)
	LB	210 s	4'00"(Light,normal)		Equivalent
	LBS		2'30"(Light,Fast)
Consistency	MB	32.75 mm	34.76 mm(Heavy,normal)	[ISO4823:20217.2]	Equivalent
	HB		34.78 mm(Heavy, Fast)	<= 35 mm
	LB	48.83 mm	43.43 mm(Light, normal)	[ISO4823:20217.2]	Equivalent
	LBS		42.02 mm(Light, Fast)	> =36 mm
Compatibility withgypsum	MB	Reproduced for0.05 mm	Reproduced for0.05 mm	[ISO4823:20217.6]	Equivalent
	HB			50 µm shouldbe reproducedwithoutinterruption.
	LB	Reproduced for0.05 mm	Reproduced for0.05 mm		Equivalent
	LBS
Strain incompression (Curveof the shrinkage)	MB	1.2 %	2.56 % (Heavy,normal)	[ISO 4823:2021 7.8]it should bewithin0.8~20 %	SimilarBoth conformsto the standard
	HB		2.38 % (Heavy,Fast)
	LB	3.1 %	7.71 % (Light,normal)	[ISO 4823:2021 7.8]within2.0~20 %	SimilarBoth conformsto the standard
	LBS		5.24 % (Light,Fast)
Linear DimensionalChange	MB	0.12 %	0.11 % (Heavy,normal)	[ISO4823:20217.5]<= 1.5 %	SimilarBoth conformsto the standard
	HB		0.07 % (Heavy,Fast)
	LB	0.04 %	0.08 % (Light,normal)		SimilarBoth conformsto the standard
	LBS		0.09 % (Light,Fast)

{8}------------------------------------------------

{9}------------------------------------------------

510(k) Summary of Vonflex STM is provided in Appendix A_K152615

	Subject device	Predicate Device	Discuss/Justify theDifferences
510(k) Number	New	K170736	-
Trade Name	Chemi-SiL Bite-Blu	Hysil Impression MaterialsHySil Bite	-
Manufacturer	B&E KOREA Co., Ltd.	OSSTEM Implant Co., Ltd.	-
Common Name	Impression material	Impression material	Same
Device Class	2	2	Same
Product Code	ELW	ELW	Same
Indications for use	• Impression of the occlusalsurface	HySil Bite is used forimpression as below.- Taking occlusal surfaces- Confirming occlusal surfaces- Recording after putting the	Same
			articulator
	Physical State	Bite registration materials	Bite registration materials	Same
Structure		Addition type silicone basedelastomeric impressionmaterials	Addition type silicone basedelastomeric impressionmaterials	Same
	Packaging	Primary packaging: CartridgeSecondary packaging: Cartonbox	Primary packaging: CartridgeSecondary packaging: Cartonbox	Same
Usage		Single patient, single use.Not reusable	Single patient, single use.Not reusable	Same
	Sterility	Non-sterile	Non-sterile	Same
	Handling System	Two part base/catalyst system	Two part base/catalyst system	Same
	Type of Curing	Self-curing after Hand-kneaded mixes	Self-curing after Hand-kneaded mixes	Same
Physical properties	Colours	Pass	Pass	SameThe classification ofthe subject andpredicate device iscomplied with DIN13903
	Working time	55 s	Pass
	Minimumperiod spent inthe mouth	95 s	1 min. 30 sec
	Recovery afterDeformation	0.0 mm	more than 0.1 mm
	Loadenduranceduringbending(Flexural strength)	8.2 N(20 s)	Pass
	Hardnessdegree(HD)	50 HD	50 HD
	Lineardimensionalchange	0.3 %	-0.16 %
Chemicalcomposition	Poly(dimethylsiloxane), vinylterminated	Vinylpolysiloxane	Similar
	Hydrophilic fumed SilicaSynthetic amorphous Silica		Both device arecomposed of vinylterminated siloxane,Filler, platinumcatalyst andpigment.
	Pigment
	Platinum complex
Biocompatibility	Meets ISO 10993-1 for asurface device contactingmucosal membrane and dentinfor a short-term contactduration (>24h)	Conforms with ISO 10993-1	Same
Standardsconformed	DIN 13903ISO 10993-1	DIN 13903ISO 10993-1	Same

{10}------------------------------------------------

{11}------------------------------------------------

510(k) Summary of Hysil Impression Materials HySil Bite is provided in Appendix B K170736

8. CONCLUSION

Subject devices have the same intended use and the principle of operation as the predicate devices. They are intended to perform as impression materials which meet the requirements according to ISO 4823. Both subject and predicate devices are classified under the same product code (ELW) and have equivalent indications of use (crown and bridge impressions, inlay and onlay impressions for Chemi-SiL (HB, MB, LB, LBS), and impression of the occlusal surface for Chemi-SiL Bite-Blu).

Both devices demonstrate similar physical properties and biocompatibilities with comparable performance specifications to the predicate devices. Information about working time, setting reaction time, consistency, compatibility with gypsum, strain in compression, and linear dimensional change is compared between Chemi-SiL (HB, MB, LB, LBS) and Vonflex STM. Colour, working time, minimum period spent in the mouth, recovery after deformation, load endurance (flexural strength), hardness degree (HD), and linear dimensional change are compared between Chemi-SiL Bite-Blu and Hysil Impression Materials HySil Bite. All subject

{12}------------------------------------------------

devices have shown better or equivalent performance compared to the predicate device, or have shown compliance with the device-specific standard (ISO 4823) at each endpoint.

In terms of chemical equivalence, the chemical constituents of both devices are analyzed and classified into comparable molecular subgroups. Even though the exact materials do not necessarily coincide, the essential composition of the same; vinyl-terminated siloxane, cross-linking siloxane, silica filler, platinum catalyst, pigments, and surfactant.

In terms of biological equivalence, the bench and biocompatibility testing performed demonstrate that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that the subject devices are substantially equivalent to the predicate devices.

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).