ESTENIA

K982164 · Kuraray America, Inc. · EBF · Aug 10, 1998 · Dental

Device Facts

Record IDK982164
Device NameESTENIA
ApplicantKuraray America, Inc.
Product CodeEBF · Dental
Decision DateAug 10, 1998
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3690
Device ClassClass 2
AttributesTherapeutic

Intended Use

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.

Device Story

ESTENIA is a resin-based crown and bridge material used in dental laboratories for fabricating jacket crowns, facing crowns, inlays, and onlays. The device consists of body resin, opaque resin, opaque primer, modeling liquid, add-on, and air-barrier paste. It utilizes a dual-curing mechanism involving both light-activation and heat-activation for polymerization. The material is composed of dimethacrylate monomers and inorganic fillers. Dental technicians use the material to build up restorations, which are then cured to achieve mechanical strength. The final output is a dental restoration (crown, inlay, or onlay) that is placed by a dentist to restore tooth structure. The device provides a restorative option for patients requiring dental crowns or bridges, including those in stress-bearing areas.

Clinical Evidence

Bench testing only. Physical properties (flexural strength, flexural modulus, water absorption, solubility, color stability) were evaluated using modified ISO 10477 methods. Mechanical strength (compressive and flexural) was compared against predicate devices (CONQUEST, ARTGLASS). Biocompatibility testing included acute toxicity (LD50), Ames mutagenicity tests (genotoxicity), oral mucous membrane irritation (hamster model), and sensitization (maximization test) per ISO 10993 and ANSI/ADA standards. Results indicated no toxicity, no genotoxicity, and no irritation/sensitization.

Technological Characteristics

Resin-based crown and bridge material composed of dimethacrylate monomers and inorganic fillers. Activation system: light-activation followed by heat-activation. Components include Body Resin, Opaque Resin, Opaque Primer, Modeling Liquid, Add-on, and Air-Barrier Paste. Evaluated for flexural strength, water absorption, and solubility. Not classified under ISO 10477:1992 due to unique dual-cure activation system and suitability for stress-bearing posterior areas.

Indications for Use

Indicated for laboratory fabrication of jacket crowns, facing crowns, and inlays/onlays. For prescription use only.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{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-: +81-6-348-2603 Phone Facsimile: +81-6-348-2552 # 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<br>Dental Material Department<br>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<br>York, NY 10166 | | 3) Telephone | (212)986-2230 | | 4) Facsimile | (212)876-3543 | | 5) Contact person | Koji Fijita<br>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<br>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<br>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, {1}------------------------------------------------ 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<br>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<br>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<br>KULZER, INC. | (K940800) | | | 3) Inlay and onlay | | | 1) | TARGIS SYSTEM by IVOCLAR NORTH AMERICA, INC. | (K962878) | | 2) | BELLEGLASS HP DENTAL LABORATORY CROWN AND<br>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 3) 4) - 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) {6}------------------------------------------------ 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, 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 {8}------------------------------------------------ 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)
Innolitics
510(k) Summary
Decision Summary
Classification Order
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