(76 days)
The Apollo 95E produces visible light for the polymerization of dental materials and for tooth whitening.
Not Found
I apologize, but the provided text from the FDA 510(k) letter for the Apollo 95E device does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document is a clearance letter indicating that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device. It defines the "Indications For Use" for the Apollo 95E as producing visible light for the polymerization of dental materials and for tooth whitening.
However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about a study to prove the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Information on expert qualifications or adjudication methods.
- Whether MRMC or standalone performance studies were conducted.
- The type of ground truth used.
This type of information would typically be found in the 510(k) submission itself, which is a much more extensive document that includes details of testing and performance data. The letter provided is merely the FDA's decision based on that submission.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1998
Dental/Medical Diagnostic Systems, Incorporated C/O Mr. Greq Holland Consultant to DMD Holland & Associates 3722 Avenue Sausalito Irvine, California 92606
Re : K981948 Trade Name: Apollo 95E Requlatory Class: II Product Code: EBF June 1, 1998 Dated: Received: June 3, 1998
Dear Mr. Holland:
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 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). 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. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Administration (FDA) will verify such assumptions. Failure to 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
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Page 2 - Mr. Holland
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 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" (21CFR 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.qov/cdrh/dsma/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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Premarket Notification - Dental/Medical Diagnostic Systems, Inc.
Page 1_ of _1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Apollo 95E produces visible light for the polymerization of dental materials and for tooth whitening.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runa
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
June 1, 1998
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§ 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.