ESTENIA

• K Number: K982164
• Device Name: ESTENIA
• Manufacturer: KURARAY AMERICA, INC.
• Date Cleared: 1998-08-10 ( 52 days)
• Product Code: EBF EBE
• Regulation Number: 872.3690

Intended Use

This device is used for the following indications. Each indication is same to that of similar products. 1) Jacket crown 2) Facing crown 3) Inlay and onlay

Device Description

ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers › intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations. ESTENIA consists of Body Resin, Opaque Resin, Opaque Primer, Modeling Liquid, Add-on Primer, Air-Barrier Paste and accessories.

Predicate Devices

K962878, K955331, K954115, K972292, K964578, K940800, K932154

Reference Devices

K943169, K933030, K871635, K925383, K965091, K974486, K943168, K855211, K802683, K940800

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental resin material and its physical properties, with no mention of AI or ML.

Therapeutic

No.
The device is a restorative material for laboratory fabrication of dental crowns and inlays, which are used to restore structure and function rather than treat or prevent a disease or condition.

Diagnostic

No
The device, ESTENIA, is described as a "tooth shade resin material ... intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations." It is a restorative material used in dental fabrication, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of materials like dimethacrylate monomers and inorganic fillers and includes components like Body Resin, Opaque Resin, etc., indicating it is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The intended uses are for fabricating dental restorations (jacket crown, facing crown, inlay, and onlay). These are physical devices used to restore the structure and function of teeth.
• Device Description: The description clearly states it's a "tooth shade resin material" composed of materials used for "laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations." This describes a material used to create a physical product, not a test performed on a biological sample.
• Lack of IVD Characteristics: There is no mention of:
  • Analyzing biological samples (blood, urine, tissue, etc.).
  • Providing information about a patient's health status, disease, or condition.
  • Performing a test or assay.
  • Any diagnostic purpose.

The device is a dental material used in a laboratory setting to create dental prosthetics. This falls under the category of dental devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device is used for the following indications. Each indication is same to that of similar products.

1. Jacket crown
2. Facing crown
3. Inlay and onlay

Product codes (comma separated list FDA assigned to the subject device)

EBE

Device Description

ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers › intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations.
ESTENIA consists of Body Resin, Opaque Resin, Opaque Primer, Modeling Liquid, Add-on These components are similar to that of the Primer, Air-Barrier Paste and accessories. products in the paragraph 4 of this summary.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

laboratory fabrication

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Following physical properties of Body Resin, Enamel, Dentin, Cervical and Transparent are evaluated with modified test methods. All specimens were prepared under light and heat polymerization. All test results fulfill the requirements of ISO 10477 excluding the test methods.

• a) Light-curing according to the final polymerization condition described in the draft instructions for use.
• b) Heat-curing according to the draft instructions for use after light-curing.

To compare performance of ESTENIA with that of the predicated device, compressive strength and flexural strength are evaluated using the house test methods. The mechanical strengths of ESTENIA are substantially equivalent to that of products sold in the U.S. market.

The biocompatibility of AL-C, MUS, MPA, DMAEM and HD were evaluated its acute toxicity (LD50) and genotoxicity. Additionally, oral mucos membrane irritation test and maximization test were performed with cured Body Resin. Furthermore, acute toxicity of leachables was investigated on Body Resin, Opaque with Opaque Primer and Modeling liquid. These results suggest that ESTENIA is a safe dental device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Flexural strength (MPa): Transparent 135, Enamel 157, Dentin 175, Cervical 107
Flexural modulus (MPa): Transparent 1.7 x10^4, Enamel 2.3 x10^4, Dentin 1.9 x10^4, Cervical 2.3 x10^4
Minimum strength (MPa): Transparent 83, Enamel 98, Dentin 88, Cervical 71
Water absorption (µg/mm³): Transparent 11, Enamel 7, Dentin 7, Cervical 8
Solubility (µg/mm³): Transparent -2, Enamel -3, Dentin -3, Cervical -2
Colour stability: no change for all (Transparent, Enamel, Dentin, Cervical)

Compressive strength (MPa): ESTENIA 620, CONQUEST 473, ARTGLASS 340
Flexural strength1 (MPa): ESTENIA 202, CONQUEST 160, ARTGLASS 121

LD50 for AL-C: not less than 3,000 mg/kg
Genotoxicity for AL-C: Negative

LD50 for MUS: not less than 8,000 mg/kg
Genotoxicity for MUS: Negative

LD50 for MPA: not less than 4,000 mg/kg
Genotoxicity for MPA: Negative

LD50 for HD: not less than 3,000 mg/kg
Genotoxicity for HD: Negative

LD50 for DMAEM: not less than 2,055 mg/kg
Genotoxicity for DMAEM: Negative

Oral mucos membrane irritation test of cured resin: Negative
Sensitization test (Maximization test) of cured resin: Negative

Acute toxicity of leachables: No group indicating weight change and no mouse died.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC. (K962878), BELLEGLASS HP DENTAL LABORATORY CROWN AND BRIDGRE FABLICATION SYSTEM by KERR CORP. (K955331), ARTGLASS & KEVLOC by HERAEUS KULZER, INC. (K954115), SOLIDEX by SHOFU DENTAL CORP. (K972292), FIBREKOR by JENERIC/PENTRON, INC. (K964578), DENTACOLOR VITA(VS) SHADE SYSTEM by HERAEUS KULZER, INC. (K940800), CONQUEST CRYSTAL by JENERIC/PENTRON, INC. (K932154)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

CLEARFIL LINER BOND 2 by Kuraray Co., Ltd. (K943169), PANAVIA 21 by Kuraray Co., Ltd. (K933030), CLEARFIL POSTERIOR 3 by Kuraray Co., Ltd. (K871635), PHOTO CLEARFIL OPAQUER by Kuraray Co., Ltd. (K925383), TEETHMATE F-1 by Kuraray Co., Ltd. (K965091), CLEARFIL LINER BOND 2V by Kuraray Co., Ltd. (K974486), CLEARFIL AP-X by Kuraray Co., Ltd. (K943168), PANAVIA EX; A Dental Adhesive by Kuraray Co., Ltd. (K855211), HELIOSIT by Vivadent (USA) Inc. (K802683), DENTACOLOR VITA(VS) SHADE SYSTEM by Heraeus Kulzer Inc. (K940800)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.

Summary

0

K982164
[ESTENIA, Kuraray]

Image /page/0/Picture/1 description: The image is a logo for Kuraray. The logo features a stylized letter "K" with a geometric design. The word "KURARAY" is printed in a bold, sans-serif font below the letter "K". The logo is black and white.

12-39, 1-Chome, Umeda, Kita-ku, Osaka 530-: [phone] Phone Facsimile: [phone]

AUG | 0 1998

KURAR

510(K) SUMMARY

1. Submitter

1) Name	KURARAY CO., LTD.
2) Address	1-12-39, Umeda, Kita-ku, Osaka 530-8611, Japan
3) Telephone	81(Japan)6-348-2603
4) Facsimile	81(Japan)6-348-2552
5) Contact person	Yoshinori Nagase
Dental Material Department
Medical Products Division
6) Date	June 3, 1998

2. Representing (Subsidiary of KURARAY CO., LTD)

1) Name	KURARAY AMERICA Inc.
2) Address	30th FI. Metlife Building, 200 Park Avenue, New
York, NY 10166
3) Telephone	[phone]
4) Facsimile	[phone]
5) Contact person	Koji Fijita
President

3. Name of Device

1) Proprietary Name	ESTENIA
2) Classification Name	Tooth shade resin material (21CFR 872.3690
3) Common/Usual Name	Resin-based crown and bridge material

4. Predicate devices:

1)	TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC.	(K962878)
2)	BELLEGLASS HP DENTAL LABORATORY CROWN AND
BRIDGRE FABLICATION SYSTEM by KERR CORP.	(K955331)
3)	ARTGLASS & KEVLOC by HERAEUS KULZER, INC.	(K954115)
4)	SOLIDEX by SHOFU DENTAL CORP.	(K972292)
5)	FIBREKOR by JENERIC/PENTRON, INC.	(K964578)
6)	DENTACOLOR VITA(VS) SHADE SYSTEM by HERAEUS
KULZER, INC.	(K940800)
7)	CONQUEST CRYSTAL by JENERIC/PENTRON, INC.	(K932154)

5. Description for the premarket notification

ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers › intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations.

This product is similar and substantially equivalent in design, composition and function to the similar products which are identified in the paragraph 4 of this summary; all of which are safe,

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effective and beneficial.

• 6. Statement of the intended use.
     This device is used for the following indications. Each indication is same to that of similar products.
• 1. Jacket crown

1)	TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC.	(K962878)
2)	BELLEGLASS HP DENTAL LABORATORY CROWN AND
BRIDGRE FABLICATION SYSTEM by KERR CORP.	(K955331)
3)	ARTGLASS & KEVLOC by HERAEUS KULZER, INC.	(K954115)
4)	FIBREKOR by JENERIC/PENTRON, INC.	(K964578)
	2) Facing crown
1)	TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC.	(K962878)
2)	BELLEGLASS HP DENTAL LABORATORY CROWN AND
BRIDGRE FABLICATION SYSTEM by KERR CORP.	(K955331)
3)	ARTGLASS & KEVLOC by HERAEUS KULZER, INC.	(K954115)
4)	SOLIDEX by SHOFU DENTAL CORP.	(K972292)
5)	FIBREKOR by JENERIC/PENTRON, INC.	(K964578)
6)	DENTACOLOR VITA(VS) SHADE SYSTEM by HERAEUS
KULZER, INC.	(K940800)
	3) Inlay and onlay
1)	TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC.	(K962878)
2)	BELLEGLASS HP DENTAL LABORATORY CROWN AND
BRIDGRE FABRICATION SYSTEM by KERR CORP.	(K955331)
3)	ARTGLASS & KEVLOC by HERAEUS KULZER, INC.	(K954115)
4)	FIBREKOR by JENERIC/PENTRON, INC.	(K964578)

• Statement of the technological characteristics and safety 7.
  ESTENIA is developed to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay. ESTENIA is substantially equivalent in design, components and function to that of products sold in the U.S. market.

• 7-1 Components
  ESTENIA consists of Body Resin, Opaque Resin, Opaque Primer, Modeling Liquid, Add-on These components are similar to that of the Primer, Air-Barrier Paste and accessories. products in the paragraph 4 of this summary.

7-2 Applicable standard

There is an ISO standard, ISO 10477:1992, applicable to resin-based crown and bridge This standard covers polymer-based crown and bridge materials for anterior materials. restoration, and has the classification on their activation system. This standard is not applicable to ESTENIA because of following reasons.

• a) ESTENIA can not be classified according to the section 4 of this standard because of its special activation system; i.e., light-activation plus heat-activation.
• b) The intended purpose of ESTENIA includes posterior crown including stress-bearing

2

areas.

Following physical properties of Body Resin, Enamel, Dentin, Cervical and Transparent are evaluated with modified test methods. All specimens were prepared under light and heat polymerization. All test results fulfill the requirements of ISO 10477 excluding the test methods.

• a) Light-curing according to the final polymerization condition described in the draft instructions for use.
• b) Heat-curing according to the draft instructions for use after light-curing.

	Transparent	Enamel	Dentin	Cervical
1) Flexural strength (MPa)	135	157	175	107
Flexural modulus (MPa)	$1.7 x10^4$	$2.3 x10^4$	$1.9 x10^4$	$2.3 x10^4$
Minimum strength (MPa)	83	98	88	71
2) Water absorption (µg/mm³)	11	7	7	8
3) Solubility (µg/mm³)	-2	-3	-3	-2
4) Colour stability	no change	no change	no change	no change

The reason for minus values of solubility maybe came from the storing conditions specified in the test clause of ISO 10477.

7-3 Mechanical strength in comparison with predicated devices

To compare performance of ESTENIA with that of the predicated device, compressive strength and flexural strength are evaluated using the house test methods. The mechanical strengths of ESTENIA are substantially equivalent to that of products sold in the U.S. market.

	ESTENIA	CONQUEST	ARTGLASS
Compressive strength (MPa)	620	473	340
Flexural strength1 (MPa)	202	160	121

*1: Preparation method of sample specimen is different from that described in 7-2.

7-4 Chemical ingredients

The chemical ingredients except AL-C, MUS, MPA, HD, DMAEM, JFB2 and POSL have been already used in the following products that is allowed to be sold in U.S. market.

1. CLEARFIL LINER BOND 2 by Kuraray Co., Ltd.	(K943169)
2. PANAVIA 21 by Kuraray Co., Ltd.	(K933030)
3. CLEARFIL POSTERIOR 3 by Kuraray Co., Ltd.	(K871635)
4. PHOTO CLEARFIL OPAQUER by Kuraray Co., Ltd.	(K925383)
5. TEETHMATE F-1 by Kuraray Co., Ltd.	(K965091)
6. CLEARFIL LINER BOND 2V by Kuraray Co., Ltd.	(K974486)
7. CLEARFIL AP-X by Kuraray Co., Ltd.	(K943168)
8. PANAVIA EX; A Dental Adhesive by Kuraray Co., Ltd.	(K855211)
9. HELIOSIT by Vivadent (USA) Inc.	(K802683)
10. DENTACOLOR VITA(VS) SHADE SYSTEM by Heraeus Kulzer Inc.	(K940800)

3

JFB2 dose not affect safety of ESTENIA, because it is a food additive and a same pigment is listed as a color additive in 21 CFR. POSL does not affect safety of ESTENIA, because a same agent is listed in NF and the component containing POSL is washed away after fabrication of restoration.

Summary of biological evaluation 8.

The biocompatibility of AL-C, MUS, MPA, DMAEM and HD were evaluated its acute toxicity Additionally, oral mucos membrane irritation test and (LD50) and genotoxicity. maximization test were performed with cured Body Resin. Furthermore, acute toxicity of leachables was investigated on Body Resin, Opaque with Opaque Primer and Modeling liquid. These results suggest that ESTENIA is a safe dental device.

8-1 AL-C

8-1-1 Acute toxicity

• Mouse Animal 1)
• Dosing route Oral 2)
• LD50; not less than 3,000 mg/kg 3) Results

8-1-2 Genotoxicity test

• Method Ames mutagenicity test 1)
• Results Negative 2)

Bacterial species	Genotoxicity
	with S-9 mix	without S-9 mix
Salmonella typhimurium TA100	Negative	Negative
Salmonella typhimurium TA1535	Negative	Negative
Escherichia coli WP2 uvrA	Negative	Negative
Salmonella typhimurium TA98	Negative	Negative
Salmonella typhimurium TA1537	Negative	Negative

This test was based on ISO 10993-3: 1992, biological evaluation of medical devices-part 3.

8-2 MUS

• 8-2-1 Acute toxicity
  • Animal Mouse 1)
  • 2. Dosing route Oral
  • 3. Results LD50; not less than 8,000 mg/kg

8-2-2 Genotoxicity test

• Ames mutagenicity test Method 1)
• 2. Results Negative

Bacterial species	Genotoxicity
	with S-9 mix	without S-9 mix
Salmonella typhimurium TA100	Negative	Negative
Salmonella typhimurium TA1535	Negative	Negative
Escherichia coli WP2 uvrA	Negative	Negative
Salmonella typhimurium TA98	Negative	Negative
Salmonella typhimurium TA1537	Negative	Negative

This test was based on ISO 10993-3: 1992, biological evaluation of medical devices-part 3.

4

8-3

. J ·

ra o Rajil

• 8-3-1 Acute toxicity
  • Mouse Animal 1).
  • Oral Dosing route 2)
  • LD50; not less than 4,000 mg/kg Results 3)

8-3-2 Genotoxicity test

• Ames mutagenicity test Method 1)
• Negative Results 2)

Bacterial species	Genotoxicity
	with S-9 mix	without S-9 mix
Salmonella typhimurium TA100	Negative	Negative
Salmonella typhimurium TA1535	Negative	Negative
Escherichia coli WP2 uvrA	Negative	Negative
Salmonella typhimurium TA98	Negative	Negative
Salmonella typhimurium TA1537	Negative	Negative

This test was based on ISO 10993-3: 1992, biological evaluation of medical devices-part 3.

8-4 HD

• Acute toxicity 8-4-1
  • Mouse 1) Animal
  • Oral Dosing route 2)
  • LD50; not less than 3,000 mg/kg 3) Results

Genotoxicity test 8-4-2

• Ames mutagenicity test 1) Method
• Results Negative 2)

Bacterial species	Genotoxicity
	with S-9 mix	without S-9 mix
Salmonella typhimurium TA100	Negative	Negative
Salmonella typhimurium TA1535	Negative	Negative
Escherichia coli WP2 uvrA	Negative	Negative
Salmonella typhimurium TA98	Negative	Negative
Salmonella typhimurium TA1537	Negative	Negative

This test was based on ISO 10993-3: 1992, biological evaluation of medical devices-part 3.

8-5 DMAEM

• 8-5-1 Acute toxicity

1) Animal	Mouse
2) Dosing route	Oral
3) Drug dose	IP, once then 0.255 mg/kg

• 3. Results LD50; not less than 2,055 mg/kg

8-5-2 Genotoxicity test

1) Method	Ames mutagenicity test
2) Results	Negative

• 2. Results

5

Bacterial species	Genotoxicity
	with S-9 mix	without S-9 mix
Salmonella typhimurium TA100	Negative	Negative
Salmonella typhimurium TA1535	Negative	Negative
Escherichia coli WP2 uvrA	Negative	Negative
Salmonella typhimurium TA98	Negative	Negative
Salmonella typhimurium TA1537	Negative	Negative

This test was based on ISO 10993-3: 1992, biological evaluation of medical devices-part 3.

·8-6 Oral mucos membrane irritation test of cured resin

• 1. Animal Hamster
• ESTENIA cured Body resin Sample 2)
• Results Negative 3)

This test was based on ANSI/ADA document No.41 (1979) for biological evaluation of dental materials.

8-7 Sensitization test (Maximization test) of cured resin

• Maximization sensitization test 1) Method
• 2. Results Negative

This test was based on ISO 10993-10: 1992, biological evaluation of medical devices-part 3.

8-8 Acute toxicity of leachables

Cured specimens of Body Resin, Opaque with Opaque Primer, and Modeling Liquid were prepared to evaluate the acute toxicity of leachables from ESTENIA.

1. Sample

• a) Body Resin(Transparent)
• Body Resin(Enamel) b)
• Body Resin(Dentin) c)
• d) Opaque with Opaque primer
• Modeling liquid e)
• Extracted media Distilled water 2)
  • Animal Mouse ICR
  • Three lots of each sample is evaluated. Cured specimens were Route of administraion immersed into distilled water in the ratio of 10ml/1g-specimen and stored at 80℃ for one hour. The extracted fluid was administrated to 10 mouse intraorally. The administrate amount was 20ml/kg-mouse. Three lots and one reference were evaluated for each sample. After seven days, weight change of each mouse was obtained.
• Result There was no group indicating weight change and no mouse died. 5)

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | 0 1998

Kuraray Co., Ltd. ·C/O Mr. Koji Fujita President Kuraray America, Incorporated 30th FI Metlife Building 200 Park Avenue New York, New York 10166-3098

Re : K982164 ESTENIA Trade Name: Requlatory Class: II Product Code: EBE June 15, 1998 Dated: Received: June 19, 1998

Dear Mr. Fujita:

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, 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 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

7

Page 2 - Mr. Fujita

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

S. Autman for

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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Image /page/8/Picture/0 description: The image shows a sequence of characters and numbers: K982164. Below the numbers, the text "[ESTENIA, Kuraray]" is visible. The characters and numbers are written in a bold, slightly rough font, giving them a distinct appearance.

510(k) Number (if known): Device Name: ESTENIA

Indications for Use

1987

• 1. Jacket crown
• 2. Facing crown
• Inlay and onlay 3)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Burns

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

• saqunn (x)015

Santa DaligsoH IstanaD Dura 1.011100 noiler Banks and Carling (110-ugi2 noisiviQ)