The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices.

AI/ML Overview

This is a 510(k) premarket notification for a dental impression material, DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), and DENU Putty Set (Regular, Fast). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the international standard ISO 4823:2021 (Dentistry - Elastomeric impression materials) and the device's performance is compared to these standards and the predicate devices.

Performance Characteristic	Acceptance Criteria (from ISO 4823:2021 or Predicate)	DENU Light Body (Regular, Fast) Reported Performance	DENU Heavy Body (Regular, Fast) Reported Performance	DENU Putty Set (Regular, Fast) Reported Performance	Performance Conclusion
Working Time	Specified by manufacturer or within predicate's range (e.g., 1'30" - 2'30" for light body)	Light Body, Regular: 1'30"	Heavy Body, Regular: 1'30"	Putty Set Regular: 1'30"	Equivalent / Similar (conforms to standard)
		Light Body, Fast: 1'30"	Heavy Body, Fast: 1'30"	Putty Set Fast: 1'30"	Equivalent / Similar (conforms to standard)
Setting Reaction Time	Specified by manufacturer or within predicate's range (e.g., 2'30" - 4'00" for light body)	Light Body, Regular: 4'10"	Heavy Body, Regular: 4'10"	Not directly reported (comparison to predicate shows equivalence)	Equivalent
		Light Body, Fast: 2'40"	Heavy Body, Fast: 2'40"		Equivalent
Consistency / Flow	Light Body: >= 36 mm (ISO 4823:2021 7.2)	Light Body, Regular: 39.18 mm			Equivalent
		Light Body, Fast: 36.16 mm			Equivalent
	Heavy Body: < 35 mm (ISO 4823:2021 7.2)		Heavy Body, Regular: 34.10 mm		Equivalent
			Heavy Body, Fast: 32.54 mm		Equivalent
	Putty Set: < 35 mm (ISO 4823:2021 7.2)			Putty Set Regular: 26.72 mm	Equivalent
				Putty Set Fast: 27.94 mm	Equivalent
Compatibility with Gypsum	50 µm to 75 µm should be reproduced without interruption (ISO 4823:2021 7.6)	Light Body, Regular: Reproduced for 0.05 mm	Heavy Body, Regular: Reproduced for 0.05 mm	Putty Set Regular: Reproduced for 75 µm	Equivalent
		Light Body, Fast: Reproduced for 0.05 mm	Heavy Body, Fast: Reproduced for 0.05 mm	Putty Set Fast: Reproduced for 75 µm	Equivalent
Strain in Compression	0.8% - 20% (ISO 4823:2021 7.8)	Light Body, Regular: 2.52%	Heavy Body, Regular: 1.54%	Putty Set Regular: 1.74%	Similar (conforms to standard)
		Light Body, Fast: 2.58%	Heavy Body, Fast: 1.10%	Putty Set Fast: 1.60%	Similar (conforms to standard)
Linear Dimensional Change / Accuracy	<= 1.5% (ISO 4823:2021 7.5)	Light Body, Regular: 0.09%	Heavy Body, Regular: 0.20%	Putty Set Regular: 0.21%	Equivalent / Similar (conforms to standard)
		Light Body, Fast: 0.13%	Heavy Body, Fast: 0.27%	Putty Set Fast: 0.17%	Equivalent / Similar (conforms to standard)
Mixing Time	<= 60 sec (ISO 4823:2021 7.1)	Not directly reported for L/H body	Not directly reported for L/H body	Putty Set Regular: 26.2"	Similar (conforms to standard)
				Putty Set Fast: 21.4"	Similar (conforms to standard)
Appearance and Component colors	Not explicitly quantified, but implied to be similar to predicate.	Met preset test criteria.	Met preset test criteria.	Met preset test criteria.	Met criteria
Detail Reproduction	Not explicitly quantified, but implied to be similar to predicate and meet ISO 4823.	Met preset test criteria.	Met preset test criteria.	Met preset test criteria.	Met criteria
Elastic recovery	Not explicitly quantified, but implied to be similar to predicate.	Met preset test criteria.	Met preset test criteria.	Met preset test criteria.	Met criteria
Cytotoxicity	Conforms to ISO 7405 and ISO 10993-1.	Met preset test criteria.	Met preset test criteria.	Met preset test criteria.	Met criteria
Skin Sensitization	Conforms to ISO 10993-10.	Met preset test criteria.	Met preset test criteria.	Met preset test criteria.	Met criteria
Oral Mucosa Irritation	Conforms to ISO 10993-10.	Met preset test criteria.	Met preset test criteria.	Met preset test criteria.	Met criteria
Acute Systemic Toxicity	Conforms to ISO 10993-11.	Met preset test criteria.	Met preset test criteria.	Met preset test criteria.	Met criteria

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

The document does not explicitly state the sample sizes for each specific physical property test (e.g., how many samples were tested for working time, consistency, etc.). The testing was based on ISO 4823:2021 and other biocompatibility standards (ISO 7405, ISO 10993-10, ISO 10993-11). These standards typically specify the number of samples required for each test. Given the context of a 510(k) submission, it is assumed that the protocol for each standard was followed, including the specified sample sizes (though not explicitly listed in this summary).

The data provenance is retrospective, as the tests have already been performed and the results are being presented. The manufacturer, HDI, Inc., is based in South Korea, implying the tests were likely conducted there or by affiliated labs.

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

This submission describes physical and biological bench testing of an impression material against established international standards. There is no mention of human expert involvement or a "ground truth" established by experts in the context of diagnostic interpretation for this type of device. The "ground truth" for these tests is the objective measurement of physical and chemical properties as defined by the ISO standards.

4. Adjudication method for the test set

Not applicable. As described in point 3, this is bench testing of physical and biological properties. There is no expert adjudication process in this context.

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 a medical device submission for a dental impression material, not an AI-powered diagnostic device. No MRMC study was performed.

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

Not applicable. This is a dental impression material, not an algorithm or AI.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily objective physical and chemical measurements as defined by:

International Standards: Specifically, ISO 4823:2021 (Dentistry - Elastomeric impression materials) and ISO 10993 series (Biological evaluation of medical devices).
Predicate Device Performance: The performance characteristics of the proposed device are directly compared to those of the predicate devices (Vonflex STM and Vonflex S Putty).

8. The sample size for the training set

Not applicable. There is no AI or machine learning component to this device, so there is no training set in the conventional sense. The "training" for the device's performance could be considered the iterative formulation and testing by the manufacturer to meet the required specifications, but this is not a data-driven training set like in AI.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question does not apply.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 7, 2022

HDI, Inc. Taekyou Kim CEO A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13209 SOUTH KOREA

Re: K222741

Trade/Device Name: DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: August 25, 2022 Received: September 9, 2022

Dear Taekyou Kim:

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. 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 located 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222741

Device Name DENU Light Body(Regular, Fast) DENU Heavy Body(Regular, Fast) DENU Putty Set(Regular, Fast)

Indications for Use (Describe) DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)

Crown and bridge impression
Inlay and onlay impression
Denture impression
Model impression

DENU Putty Set(Regular, Fast)

Crown and bridge impression
Inlay and onlay impression

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K222741

006_ 510(k) SUMMARY

Date: August 25, 2022

1. SUBMITTER

HDI, Inc.

A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do,

Republic of Korea

TEL : +82-31-735-3510

FAX : +82-31-735-3511

Contact Name: Taekyou Kim

Email: hdikorea@hanmail.net

2. DEVICE

·Trade Name: DENU Light Body(Regular, Fast) DENU Heavy Body(Regular, Fast) DENU Putty Set(Regular, Fast)

·Common Name: Impression Material

· Regulation Number 872.3660

·Class: 2

·Classification Product Code: ELW

3. PREDICATE DEVICE

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast) : K152615 Vonflex STM, Vericom Co. Ltd DENU Putty Set(Regular, Fast) Vonflex S Putty, Vericom Co. Ltd : K152518

4. DEVICE DESCRIPTION

The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further

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classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use.

Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices.

5. INDICATIONS FOR USE

DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)

Crown and bridge impression
Inlay and onlay impression
Denture impression
Model impression

DENU Putty Set(Regular, Fast)

Crown and bridge impression
Inlay and onlay impression

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 theDifferences
510(k) Number	New	K152615	-

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Trade Name	DENU Light Body(Regular, Fast)DENU Heavy Body(Regular, Fast)	Vonflex STM	-
Manufacturer	HDI, Inc.	Vericom Co. Ltd	-
Common Name	Impression material	Impression material	Same
Device Class	2	2	Same
Product Code	ELW	ELW	Same
Device Description	The DENU family of siliconeimpression materials consistsof three different viscosities(light body, heavy body, putty)for various application systems.Products are further classifiedinto Regular type and Fasttype, depending on curing time,but there is no difference onviscosity, indications for use,or scope of use.Each device is consisted of 1:1base and catalyst component,packaged in 560mL jars forDENU Putty set and 50mLsyringes for other devices.	Vonflex STM, as the additionalpolymerization silicone type, iscomposed of a two component(base and catalyst, mixing ratio1:1) hydrophilic vinylpolysiloxane impressionmaterial for all dentalimpression techniques. VonflexSTM consists of light-bodied,medium-bodied or heavy-bodied consistencies indelivery systems of cartridgesand/or tubes. It has normal setand fast set that would bedesired by the operator.	Same
Indications for use	• Crown and bridge impression• Inlay and onlay impression• Denture impression• Model impression	• 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 device havethe same intendeduse. Both devices areused for dentalimpressiontechniques accordingto their consistencies.
Physical State	Two product lines (DENULight Body, DENU heavyBody) are provided with	Various pastes with variousviscosity	SimilarBoth subject andpredicate devices are
		different viscosity.		provided 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 :Fiberboard	Primary packaging : CartridgesSecondary packaging :Fiberboard	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 baseand catalyst part.	Self-curing after mixing of baseand catalyst part.	Same
Physicalproperties	Lightbody,regular	See the table below	See the table below	Similar
	Lightbody, fast	See the table below	See the table below	Individual values ofphysical propertiesare same or similar.Every physicalproperty of predicateand subject device
	Heavybody,regular	See the table below	See the table below
	Heavybody, fast	See the table below	See the table below	conforms to therelated standard.
	Chemicalcomposition	Vinyl siloxanes	Vinyl siloxanes	Similar
		Vinyl terminatedcyclosiloxanes		Both device arecomposed of vinylterminated siloxane,cross-linking
		Siloxane and Silicone, di-Me,Me Hydrogen	Hydrogen polysiloxane
		Silica	Silica	siloxane, Filler
	Silicon dioxide	Fumed silica	platinum catalystpigments andsurfactant.
	Pt-divinyltetramethyldisiloxanein Polysiloxane	Organo platinum complex
	Pigments	Pigments
	surfactant	Surfactant
Biocompatibility	Meets ISO 10993-1 for asurface device contactingmucosal membrane and dentinfor a short-term contactduration (>24h)	Conforms with ISO 10993-1	Same
Standardsconformed	ISO 4823ISO 10993-1	ISO 4823ISO 10993-1	Same

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	DENU Light Body(Regular, Fast)	Vonflex	Standard	Discuss/Justifythe Differences
	DENU Heavy Body(Regular, Fast)	STM	Predicatedevice
	Subject device
Working time	Light body, regular	1'30"	2'30"	[ISO 4823:20217.3]	Equivalent
	Light body, fast	1'30"	1'30"	suggested valueof themanufacturer	Equivalent
	Heavy body, regular	1'30"	2'15"		Equivalent
	Heavy body, fast	1'30"	1'30"		Equivalent
Setting reaction time	Light body, regular	4'10"	4'00"	[ISO 4823:20217.3]	Equivalent
	Light body, fast	2'40"	2'30"	suggested valueof themanufacturer	Equivalent
	Heavy body, regular	4'10"	4'00"		Equivalent
	Heavy body, fast	2'40"	2'30"		Equivalent
Consistency	Light body, regular	39.18 mm	43.43 mm	[ISO 4823:20217.2]	Equivalent
	Light body, fast	36.16 mm	42.02 mm	>= 36 mm	Equivalent
	Heavy body, regular	34.10 mm	34.76 mm	[ISO 4823:20217.2]	Equivalent
	Heavy body, fast	32.54 mm	34.78 mm	< 35 mm.	Equivalent
Compatibility withgypsum	Light body, regular	Reproducedfor 0.05 mm	Reproducedfor 0.05 mm	[ISO 4823:20217.6]	Equivalent
	Light body, fast	Reproduced	Reproduced	50 µm should be	Equivalent

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		for 0.05 mm	for 0.05 mm	reproduced
	Heavy body, regular	Reproducedfor 0.05 mm	Reproducedfor 0.05 mm	withoutinterruption.	Equivalent
	Heavy body, fast	Reproducedfor 0.05 mm	Reproducedfor 0.05 mm		Equivalent
Strainincompression (Curveof the shrinkage)	Light body, regular	2.52%	7.71%	[ISO 4823:2021 7.8]it should bewithin2.0~20 %	SimilarBoth conformsto the standard
	Light body, fast	2.58%	5.24%		SimilarBoth conformsto the standard
	Heavy body, regular	1.54%	2.56%		SimilarBoth conformsto the standard
	Heavy body, fast	1.10%	2.38%		SimilarBoth conformsto the standard
Dimensionalaccuracy	Light body, regular	0.09%	0.08%	[ISO 4823:20217.5]<= 1.5 %	Equivalent
	Light body, fast	0.13%	0.09%		SimilarBoth conformsto the standard
	Heavy body, regular	0.20%	0.11%		SimilarBoth conformsto the standard
	Heavy body, fast	0.27%	0.07%		SimilarBoth conformsto the standard

510(k) Summary of Vonflex STM is provided in Appendix D_K152615 Vonflex S, Vericom

	Subject device	Predicate Device	Discuss/Justify theDifferences
510(k) Number	New	K152518	-
Trade Name	DENU Putty Set(Regular, Fast)	Vonflex S Putty	-

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Manufacturer	HDI, Inc.	Vericom Co. Ltd	-
Common Name	Impression material	Impression material	Same
Device Class	2	2	Same
Product Code	ELW	ELW	Same
Device Description	The DENU family of siliconeimpression materials consistsof three different viscosities(light body, heavy body, putty)for various applicationsystems. Products are furtherclassified into Regular typeand Fast type, depending oncuring time, but there is nodifference on viscosity,indications for use, or scope ofuse.Each device is consisted of 1:1base and catalyst component,packaged in 560mL jars forDENU Putty set and 50mLsyringes for other devices.	Vonflex STM Putty, as theadditional polymerizationsilicone type, is composed ofvinyl polysiloxane impressionmaterials that make oral tissueshape precisely.Vonflex STM Putty is veryeasy to mix and has gooddimensional stability, helps tomake precise impressiontaking.	Same
Indications for use	• Crown and bridge impression• Inlay and onlay impression	It is used for all crown, bridgeandorthodontic impressiontechniques.	SameThe subject andpredicate devicehave the sameintended use.Inlay/onlay aresmaller cavity ratherthan a crown limitedto one tooth,therefore it can alsobe used forinlay/onlay if it ispossible to obtain acrown impression.
Physical State	Various putties with various	Viscous pastes with various	Similar
		elasticities.DENU Putty Set (Fast, Regular) are provided withdifferent elasticity.	viscosity and putties withvarious elasticities	Both subject andpredicate devices areprovided as puttieswithvariouselasticities.The physical statesare similar, ascompared inphysical properties.
Structure		Addition type silicone basedelastomeric impressionmaterials	Addition type silicone basedelastomeric impressionmaterials	Same
Packaging		Primary packaging : JarSecondary packaging : carton box	Primary packaging : JarSecondary packaging : carton box	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
Physicalproperties	DENUPuttySetRegular	See the table below	See the table below	SameThe classification ofthe subject andpredicate device iscomplied with ISO4823 (Type 0).
	DENUPuttySet Fast	See the table below	See the table below
Chemicalcomposition		Vinyl siloxanesVinyl terminated	Vinyl siloxanes	SimilarBoth device are

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	cyclosiloxanes		composed of vinyl terminated siloxane,cross-linkingsiloxane, Filler,platinum catalyst,pigments andsurfactant.
	TalcDiatomiteSilicaSilicon dioxide	SilicaFumed silica
	Siloxane and Silicone, di-Me,Me Hydrogen	Hydrogen polysiloxane
	Pt-divinyltetramethyldisiloxanein Polysiloxane	Organo platinum complex
	Pigments	Pigments
		Surfactant
Biocompatibility	Meets ISO 10993-1 for asurface device contactingmucosal membrane and dentinfor a short-term contactduration (>24h)	Conforms with ISO 10993-1	Same
Standardsconformed	ISO 4823ISO 10993-1	ISO 4823ISO 10993-1	Same

	DENU Putty Set Regular	Vonflex STM	Standard	Discuss/Justify theDifferences
DENU Putty Set Fast
	Subject device	Predicate device
Dimensionalaccuracy	Putty Set Regular	0.21%	<=1.5 %	[ISO4823:20217.5]<=1.5 %	SimilarBothconforms tothe standard
	Putty Set Fast	0.17%	<=1.5 %		SimilarBothconforms tothe standard
Consistency	Putty Set Regular	26.72 mm	43.43 mm	[ISO4823:20217.2]	Equivalent
	Putty Set Fast	27.94 mm	< 35 mm	< 35 mm	Equivalent

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Compatibility withgypsum
	Putty Set Regular	Reproducedfor 75µm	75 µmreproduction	[ISO4823:20217.6]75 µm shouldbe reproduced	Equivalent
	Putty Set Fast	Reproducedfor 75µm	75 µmreproduction		Equivalent
Strain incompression(Curve of the shrinkage)	Putty Set Regular	1.74%	0.8~20 %	[ISO4823:20217.8]0.8~20 %	SimilarBothconforms tothe standard
	Putty Set Fast	1.60%	0.8~20 %		SimilarBothconforms tothe standard
Working time	Putty Set Regular	1'30"	more than orequal to thesuggested valueof themanufacturer	[ISO4823:20217.3]more than orequal to thesuggestedvalue of themanufacturer	SimilarBothconforms tothe standard
	Putty Set Fast	1'30"	more than orequal to thesuggested valueof themanufacturer		SimilarBothconforms tothe standard
mixing time	Putty Set Regular	26.2"	<= 60 sec	[ISO4823:20217.1]<= 60 sec	SimilarBothconforms tothe standard
	Putty Set Fast	21.4"	<= 60 sec		SimilarBothconforms tothe standard

510(k) Summary of Vonflex S Putty is provided in Appendix E_K152518 Vonflex S Putty, Vericom

8. SUBSTANTIAL EQUIVALENCE DISCUSSION

Subject devices have the same Indications for Use and the principle of operations as the predicate devices. They are intended to perform as impression material which met the requirement according to ISO 4823. They demonstrate similar physical properties and biocompatibilities with comparable performance specifications to the predicate devices.

In terms of physical equivalence, information about working time, setting reaction time, consistency, compatibility with gypsum, strain in compression, dimensional accuracy,

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flow properties, tear strength, viscosity, wettability is measured by performance test or retrieved from manufacturer. Among those physical properties, values present on both predicate device and subject device, or values specified by ISO 4823 are compared to show equivalence, better performance, or conformation to the related standard on each endpoint.

In terms of clinical equivalence, both subject and predicate device are classified under the same product code(ELW), and have equivalent indication of use (crown, bridge, and other orthodontic impression).

In terms of chemical equivalence, chemical constituents of both devices are analyzed and classified into comparable molecular subgroup. Even though the exact material does not necessarily coincide on each subgroup, essential composition of the subgroup is the same; vinyl terminated siloxane, cross-linking siloxane, Filler, platinum catalyst, pigments, and surfactant.

In terms of biological equivalence, the bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that 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).