(79 days)
No
The document describes a traditional dental restorative material and does not mention any AI or ML components.
No
The device is a restorative material for dental cavities, designed to fill and restore damaged teeth. It is not indicated for treating diseases or conditions but rather for the repair of existing structural damage to teeth.
No
Explanation: The device is a restorative material used for filling cavities and core-buildup, not for diagnosing medical conditions.
No
The device description clearly states it is a "fast-setting, high viscosity radiopaque chemical curing glass ionomer restorative material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material used for restoring teeth (filling cavities, core-buildup). This is a direct treatment or repair of a physical structure within the body.
- Device Description: The description details a restorative material (glass ionomer) applied directly to the tooth.
- Lack of Diagnostic Purpose: There is no mention of this device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to analyze blood, urine, tissue samples, etc.
- Performance Studies: The performance studies focus on biocompatibility and meeting standards for dental cements, not on diagnostic accuracy or performance related to analyzing biological samples.
Therefore, this device is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Advanced Glass Ionomer (K-130) Restorative Material is indicated for semi-permanent restorations of class I and II cavities in posterior teeth; Restoration of deciduous teeth; Restoration of Class V lesions and cavities; Restoration of Class III cavities; Base/ Core-buildup. When used as a core-build-up, 2/3 of the remaining coronal dentine or at least 2mm of circumferential coronal dentine should be left for retention.
Product codes
EMA, EBF, EBC, and EJK
Device Description
Advanced Glass Ionomer (K-130) is a fast-setting, high viscosity radiopaque chemical curing glass ionomer restorative material. The restorative is available in 5 shades and comes in mixing capsules for direct application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth
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
Non-Clinical Performance Data.
A cytotoxicity test was performed for the Advanced Glass Ionomer (K-130) Restorative material as well as chemical analyses of leachable organic and inorganic compounds. The Advanced Glass Ionomer (K-130) Restorative material has been demonstrated as biocompatible and safe for its intended use.
In-vitro bench tests were performed on the Advanced Glass Ionomer (K-130) Restorative material. The results indicated that the Advanced Glass Ionomer (K-130) Restorative material meets or exceeds the requirements of ISO-9917:2007 (Dentistry: Water based cement, Part I, Powder/Liquid acid-base cements) and safe for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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1 .
510(k) SUMMARY for
Advanced Glass Ionomer (K-130) Restorative
DENTSPLY International
World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 (800) 877-0020 Fax (717) 849-4343 www.dentsply.com
AUG 1 9 2010
- Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
Contact Person: Helen Lewis Telephone Number: 717-849-4229 Fax Number: 717-849-4343
Date Prepared: 25 May 2010
2. Device Name:
- Proprietary Name: . Advanced Glass Ionomer (K-130) Restorative
- Classification Name: . . Cement, Dental
- CFR Number: 872.3275
II
- Device Class: .
- . Product Code: EMA
3. Predicate Device:
3M Ketac-Molar Aplicap (K960954)
4. Description of Device:
.
Advanced Glass Ionomer (K-130) is a fast-setting, high viscosity radiopaque chemical curing glass ionomer restorative material. The restorative is available in 5 shades and comes in mixing capsules for direct application.
5. Indications for Use:
Especially designed for:
-
. Semi-permanent restorations of Class I and II cavities in posterior teeth.
In addition suitable for: -
Restoration of deciduous teeth. .
-
Restoration of Class V lesions and cavities. ●
-
. Restoration of Class III cavities.
-
Base/ Core-build-up. When used as a core-build-up, 2/3 of the remaining coronal . dentine or at least 2mm of circumferential coronal dentine should be left for retention.
000010
1
- Description of Safety and Substantial Equivalence:
s
Technological Characteristics.
The technological characteristics (i.e., chemical composition and device function) of Advanced Glass Ionomer (K-130) Restorative are similar to that of the predicate device.
Non-Clinical Performance Data.
A cytotoxicity test was performed for the Advanced Glass Ionomer (K-130) Restorative material as well as chemical analyses of leachable organic and inorganic compounds. The Advanced Glass Ionomer (K-130) Restorative material has been demonstrated as biocompatible and safe for its intended use.
In-vitro bench tests were performed on the Advanced Glass Ionomer (K-130) Restorative material. The results indicated that the Advanced Glass Ionomer (K-130) Restorative material meets or exceeds the requirements of ISO-9917:2007 (Dentistry: Water based cement, Part I, Powder/Liquid acid-base cements) and safe for its intended use.
Conclusion as to Substantial Equivalence
We believe that the prior use of the glass ionomer restorative material in legally marketed devices and the performance and biocompatibility data provided support the safety and effectiveness of Advanced Glass Ionomer (K-130) Restorative material for the indicated uses.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
AUG 1 9 2010
Re: K101493
Trade/Device Name: Advanced Glass Ionomer (K-130) Restorative Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA, EBF, EBC, and EJK Dated: May 28, 2010 Received: June 1, 2010
Dear Ms. Lewis:
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.\
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Page 2 - Ms. Helen Lewis
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
hh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE STATEMENT
201493
510(k) Number (if known):
Device Name: Advanced Glass Ionomer (K-130) Restorative
Indications for Use:
Advanced Glass Ionomer (K-130) Restorative Material is indicated for semi-permanent restorations of class I and II cavities in posterior teeth; Restoration of deciduous teeth; Restoration of Class V lesions and cavities; Restoration of Class III cavities; Base/ Core-buildup. When used as a core-build-up, 2/3 of the remaining coronal dentine or at least 2mm of circumferential coronal dentine should be left for retention.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Reis Marley for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101493
Advanced Glass Ionomer (K-130) Restorative
000009