(170 days)
Indications are very widespread in the field of oral surgery ranging from
- A. Implant placement, including
-
- preparation of the osteotomy site
-
- bone recontouring, osteoplasty
-
- B. Bone grafting
-
- Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
-
- harvesting autogen living bone
-
- sinus elevation & grafting of alveolar sockets
-
- C. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
- D. Periodontal surgeries
-
- bone recontouring & alveoplasty around living teeth
-
- removal of exostosis
-
- E. Endodontic treatment Intracanal preparations using rotating NiTi-files.
Not Found
This document is a 510(k) clearance letter from the FDA for the ELCOmed 100 and ELCOmed 200 devices. It states that the devices are substantially equivalent to previously marketed devices. However, this letter does not contain any specifics regarding acceptance criteria, device performance, or details of a study that proves the device meets such criteria.
The information provided only includes:
- Device Name: ELCOmed 100 and 200
- 510(k) Number: K972889
- Indications for Use: A list of oral surgery-related procedures the device is intended for.
- Regulatory Class: I
- Product Code: EBW
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or its data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or its effect size.
- Standalone performance study for the algorithm.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, one would typically need to refer to the full 510(k) submission, which would contain detailed validation studies and performance data.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 222 1998
Mr. Herbert Traschwandtner W & H Dentalwerk Ignaz-Glazer-Strasse 53 Burmoos AUSTRIA
K972889 Re :
ELCOmed 100 Types 9925 (W&H- and Innova-Trade Name: Version) and 9927 (ASTRA-Version), and ELCOmed 200 Type 9926 (W&H-Version) Regulatory Class: I Product Code: EBW Dated: December 4, 1997 Received: December 8, 1997
Dear Mr. Traschwandertner:
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 reqistration, listing of devices, good manufacturing practice, labelinq, 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. ਕਿ 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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
{1}------------------------------------------------
Page 2 - Mr. Traschwandtner
not affect any obligation you might have under sections 531 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 labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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
Directo 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): | K972889 |
|---|---|
| Device Name: | FLCO med 100 and 200 |
Indication For Use:
Indications are very widespread in the field of oral surgery ranging from
- A. Implant placement, including
-
- preparation of the osteotomy site
-
- bone recontouring, osteoplasty
-
- B. Bone grafting
-
- Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
-
- harvesting autogen living bone
-
- sinus elevation & grafting of alveolar sockets
-
- C. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
- D. Periodontal surgeries
-
- bone recontouring & alveoplasty around living teeth
-
- removal of exostosis
-
- E. Endodontic treatment Intracanal preparations using rotating NiTi-files.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quarer
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.