(112 days)
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Not Found
No
The summary provides no information about the device's internal workings or any mention of AI/ML terms. The description focuses solely on the intended use and applications of a dental restorative material.
No
The device is described as suitable for various dental restorations and procedures, such as fillings, sealants, and repairs, which are not typically considered therapeutic treatments. These procedures aim to restore the structure and function of teeth rather than treating a disease or condition in the way a therapeutic device would.
No
This device is described as suitable for restorative dental procedures, such as fillings, sealants, and repairs, indicating it is a treatment device, not a diagnostic one.
No
The description focuses on dental restorative materials and procedures, not software. There is no mention of software as the primary component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used directly on teeth for restorative procedures (fillings, veneers, sealants, etc.). This is a direct clinical application within the body (or on a part of the body).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
The description clearly indicates a device used for dental procedures, not for testing biological samples.
N/A
Intended Use / Indications for Use
Suitable for routine use in conservative Class III and V restorations, for small non stress-bearing Class IV restorations, for minimal Class I restorations and for Gingival Wall of Class II restorations.
Wave is also suitable for:-
Veneers: Sealing teeth after air abrasion: Paediatric restorations; Minimal Class I and II restorations; Small restorations for enamel defects; Small occlusal build ups; Incisal abrasions: Minor core build ups: Splinting teeth; Porcelain repairs: Luting cement; Pit & fissure sealant.
Product codes
EBE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Samantha J. Cheetham Official Correspondent Southern Dental Industrial, Incorporated 246 First Street, Suite 204 San Francisco, California 94105
DEC - 8 1997
Re : K973091 Trade Name: WAVE Requlatory Class: II Product Code: EBE October 17, 1997 Dated: Received: October 22, 1997
Dear Ms. Cheetham:
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 The general controls provisions of the Act 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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Ms. Cheetham
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,
Timothy A. Ulatowski
Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
WAVE
Device Name:
Indications For Use:
Suitable for routine use in conservative Class III and V restorations, for small non stress-bearing Class IV restorations, for minimal Class I restorations and for Gingival Wall of Class II restorations.
Wave is also suitable for:-
Veneers: Sealing teeth after air abrasion: Paediatric restorations; Minimal Class I and II restorations; Small restorations for enamel defects; Small occlusal build ups; Incisal abrasions: Minor core build ups: Splinting teeth; Porcelain repairs: Luting cement; Pit & fissure sealant.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-Our)
Division of Dantal Infection Control, and General Hospital Devices Ka7209 510(k) Number
પ્રદ Prescription Use: (Per 21 CFR 801.109)
OR
Over-The-Counter Use: __ N >
(Optional Format 1-2-96)