(89 days)
K#011685
K#062410,K#123397,K#101787
No
The device description and performance studies focus on the physical and chemical properties of a dental adhesive resin cement, with no mention of AI or ML capabilities.
No.
The device is an adhesive resin cementation system used for dental restorations, not a device intended for direct therapeutic treatment of a disease or condition.
No
The device is an adhesive resin cementation system used for various dental restorations, not for diagnosing conditions. It is used to bind materials together, not to detect or identify a disease or condition.
No
The device description clearly states that the ESTECEM device is a physical adhesive resin cement system with components like paste, primer, syringes, bottles, mixing dish, applicator, and mixing tip. It is a physical product used for dental procedures, not a software application.
Based on the provided information, the ESTECEM device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an adhesive resin cement for bonding dental restorations (crowns, bridges, etc.) to teeth. This is a therapeutic or restorative use, not a diagnostic one.
- Device Description: The description details the components as pastes and primers used for adhesion. These are materials used in a dental procedure, not for analyzing biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze any biological sample (blood, urine, tissue, etc.) to diagnose a condition or disease.
- Performance Studies: The performance studies focus on physical properties and biocompatibility, which are relevant to a dental cement, not a diagnostic test.
In summary, the ESTECEM device is a dental material used for bonding, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ESTECEM device is an adhesive resin cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for:
- Repair of fractured porcelain fused to metal crowns and all ceramic restorations
- Cementation of veneers
- Cementation of adhesion bridges
- Cementation of metal or resin cores, metal or glass-fiber posts
Product codes
EMA
Device Description
The ESTECEM device is a dual-cure (light and/or self-cure), radiopaque, adhesive resin cement system with excellent handling, esthetic and adhesive properties to teeth and all prosthetic materials. The main components of the ESTECEM device are (1) the paste (A/B) and (2) primer kit. The paste and primer are packaged in plastic syringes and plastic bottles, respectively. The device also comes with a mixing dish (dispensing well), disposable applicator, and cement mixing tip.
The paste is dispensed in an automix syringe and is available in various shades (universal, clear, brown and white-opaque). The primer kit components consist of ESTELINK (bond A/bond B) and Tokuyama Universal Primer (A/B). The ESTELINK bond promotes the adhesion of the paste to the tooth structure. The Tokuyama Universal Primer enhances the adhesion of the paste to prosthetic materials.
The ESTECEM device does not come sterilized and is not intended to be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical testing of the physical properties of the ESTECEM device were conducted, including film thickness, working time, setting time, flexural strength, water sorption. color stability, radio-opacity, tensile strength, and biocompatibility testing in accordance with ISO 4049:2009, ISO 7405:2008, and ISO 10993-1:2009, ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BISTITE II DC (K#011685)
Reference Device(s)
CLEARFIL ESTHETIC CEMENT & DC BOND (K#062410), MULTILINK AUTOMIX (K#123397), DUOLINK II (K#101787)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
Tokuyama Dental Corporation c/o Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street NW Suite 1100 Washington, DC 20005
Re: K150727
Trade/Device Name: ESTECEM Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 13, 2015 Received: March 20, 2015
Dear Mr. Barritt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name ESTECEM
Indications for Use (Describe)
The ESTECEM device is an adhesive resin cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for:
-
Repair of fractured porcelain fused to metal crowns and all ceramic restorations
-
Cementation of veneers
-
Cementation of adhesion bridges
-
Cementation of metal or resin cores, metal or glass-fiber posts
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!."
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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."
3
510(k) SUMMARY Tokuyama Dental Corporation
ESTECEM Adhesive Resin Cement
The following information is provided pursuant to 21 CFR 807.92.
807.92(a)(1): Submitter's Name and Address
(i) 510(k) Submitter
Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: 011-81-3-3835-2261
(ii) 510(k) Submitter Contact
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 barritt@fr.com Email:
(iii) Preparation Date
March 9, 2015
807.92(a)(2): Name of Device
Trade or Proprietary Name: Common Name: Classification Name: Product Code: Regulation:
ESTECEM dental adhesive resin cement cement, dental EMA 21 CFR 872.3275
4
807.92(a)(3): Predicate Devices
The ESTECEM adhesive resin cement device is substantially equivalent for purposes of FDA medical device regulations to multiple predicate devices with respect to performance and biocompatibility. namely to the Primary Predicate BISTITE II DC (K#011685, Health Canada license no. 60061) and Reference Devices CLEARFIL ESTHETIC CEMENT & DC BOND (K#062410, Health Canada license no. 73128); MULTILINK AUTOMIX (K#123397, Health Canada license no. 79221); and DUOLINK II (K#101787, Health Canada license no. 30968). Additional information regarding the predicate devices appears at the end of this 510(k) Summary.
807.92(a)(4): Device Description
The ESTECEM device is a dual-cure (light and/or self-cure), radiopaque, adhesive resin cement system with excellent handling, esthetic and adhesive properties to teeth and all prosthetic materials. The main components of the ESTECEM device are (1) the paste (A/B) and (2) primer kit. The paste and primer are packaged in plastic syringes and plastic bottles, respectively. The device also comes with a mixing dish (dispensing well), disposable applicator, and cement mixing tip.
The paste is dispensed in an automix syringe and is available in various shades (universal, clear, brown and white-opaque). The primer kit components consist of ESTELINK (bond A/bond B) and Tokuyama Universal Primer (A/B). The ESTELINK bond promotes the adhesion of the paste to the tooth structure. The Tokuyama Universal Primer enhances the adhesion of the paste to prosthetic materials.
The ESTECEM device does not come sterilized and is not intended to be sterilized prior to use.
807.92(a)(5): Intended Use
The ESTECEM device is an adhesive resin cement for the cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious and non-precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for:
- Repair of fractured porcelain fused to metal crowns and all ceramic restorations
- Cementation of veneers
- Cementation of adhesion bridges
- Cementation of metal or resin cores, metal or glass-fiber posts
5
807.92(a)(6): Technological Characteristics
The ESTECEM device has the same basic technological characteristics in terms of design, material, and chemical composition as the predicate devices identified above. The ESTECEM device does not have an energy source. Although the chemical compositions are not identical, the material properties, principles of operation, and performance characteristics of the ESTECEM device are comparable to the selected predicates, as demonstrated in part by the non-clinical performance bench testing described below.
807.92(b)(1): Non-clinical Testing
Non-clinical testing of the physical properties of the ESTECEM device were conducted, including film thickness, working time, setting time, flexural strength, water sorption. color stability, radio-opacity, tensile strength, and biocompatibility testing in accordance with ISO 4049:2009, ISO 7405:2008, and ISO 10993-1:2009, ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity).
807.92(b)(2): Clinical Testing
There were no clinical tests performed for the ESTECEM device.
807.92(b)(3): Conclusions from Testing
Based on the non-clinical testing conducted of the physical properties of the ESTECEM device and the biocompatibility testing as described above, it is concluded that the ESTECEM device is as safe, as effective, and performs as well as or better than the predicate devices.
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Predicate devices
| Device name | ESTECEM | BISTITE II DC | CLEARFIL
ESTHETIC CEMENT
& DC BOND 1) | MULTILINK
AUTOMIX | DUOLINK II 2) |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Tokuyama Dental
Corporation | Tokuyama Dental
Corporation | Kuraray Noritake
Dental Inc. | Ivoclar Vivadent AG | Bisco, Inc. |
| 510(K) no. | pending | K011685 | K062410 | K123397 | K101787 |
| Licence no.
(Health
Canada) | pending | 60061 | 73128 | 79221 | 30968 |
| Device
classification
name | Cement, Dental | Cement, Dental | Cement, Dental | Material, Tooth Shade,
Resin | Cement, Dental |
| Product code | EMA | EMA | EMA | EBF | EMA |
| Indication for
use | 1. Cementation of crowns,
bridges, inlays, and onlays
made of glass/oxide ceramics
(porcelain, zirconia and
alumina), metals/alloys
(precious and non-precious)
and resin materials including
inorganic filler (composite
materials)
2. Repair of fractured
porcelain fused to metal
crowns and all ceramic
restorations
3. Cementation of veneers
4. Cementation of adhesion
bridges
5. Cementation of metal or
resin cores, metal or glass-
fiber posts | For use as dental cement in
various applications,
including luting, repair of
fractured porcelains or crown
and bridge resins, cementation
of adhesive bridge prostheses
and CR core posts | 1. Cementation of crowns,
bridges, inlays and onlays
made of porcelain, ceramic,
hybrid ceramics, composite
resin or metal
2. Cementation of veneers
3. Cementation of adhesion
bridges
4. Cementation of metal cores,
resin cores, metal posts or
glass-fiber posts | Multilink Automix is used for
the permanent cementation of
indirect restorations where a
strong bond is desired:
Inlays, onlays, crowns,
bridges and root posts made
of:
- Metal and metal ceramics
- All-ceramics, in particular
opaque zirconium oxide
ceramics - Composites and fibre-
reinforced composites | 1. All indirect restorations (i.e.
crowns.
bridges, inlay, and onlays
fabricated from
metal composite, porcelain,
ceramic, zirconia, alumina,
etc.)
- All endodontic posts (i.e.
fiber, composite and metal) - All abutments (i.e. screws) |
| Components | - Paste (A and B)
Primer Kit
- Bond A/Bond B) and
Tokuyama Universal Primer
(A/B) | - Bistite II Paste (A and B) - Primer 1 A
- Primer 1 B
- Primer 2
- Metaltite
- Tokuso Ceramic Primer A
- Tokuso Ceramic Primer B
- Air Barrier | - Paste (A and B)
- Try In Paste | - Multilink Automix (Base and
Catalyst) - Multilink Primer A
- Multilink Primer B | - Duo-Link Universal (Base
and Catalyst) |
| Principle of
operation | Dental cement that is cured by
chemical and/or photo
polymerization reaction.
(Dual-cure) | Dental cement that is cured by
chemical and/or photo
polymerization reaction.
(Dual-cure) | Dental cement that is cured by
chemical and/or photo
polymerization reaction.
(Dual-cure) | Dental cement that is cured by
chemical and/or photo
polymerization reaction.
(Dual-cure) | Dental cement that is cured by
chemical and/or photo
polymerization reaction.
(Dual-cure) |
-
This device is presumably marketed with the proprietary name as "CLEARFIL ESTHETIC CEMENT EX."
-
This device is presumably marketed with the proprietary name as "DUO-LINK UNIVERSAL."