ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)

K972889 · W & H Dentalwerk · EBW · Jan 22, 1998 · Dental

Device Facts

• Record ID: K972889
• Device Name: ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)
• Applicant: W & H Dentalwerk
• Product Code: EBW · Dental
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Indications are very widespread in the field of oral surgery ranging from A. Implant placement, including 1. preparation of the osteotomy site 2. bone recontouring, osteoplasty B. Bone grafting 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.) 2. harvesting autogen living bone 3. 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 1. bone recontouring & alveoplasty around living teeth 2. removal of exostosis E. Endodontic treatment Intracanal preparations using rotating NiTi-files.

Device Story

ELCOmed 100 and 200 are dental surgical motor systems used by oral surgeons and dentists in clinical settings. Devices provide rotational power for surgical instruments used in oral, periodontal, and endodontic procedures. System facilitates osteotomy preparation, bone harvesting, tooth sectioning, and endodontic file rotation. Operation involves electric motor control of handpieces to perform mechanical cutting, drilling, and shaping of bone and tooth structures. Output is mechanical torque and rotation delivered to surgical burs or NiTi-files. Clinicians use these systems to perform precise surgical interventions, improving efficiency and control during complex dental and bone surgeries.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental surgical motor system; electric motor-driven handpieces; designed for rotational instrumentation; intended for professional use in oral surgery; Class I device (Product Code: EBW).

Indications for Use

Indicated for oral surgery procedures including implant site preparation, bone recontouring/osteoplasty, bone grafting (donor site prep, harvesting, sinus elevation), tooth/bone removal/sectioning (impacted teeth, extractions), periodontal surgery (alveoplasty, exostosis removal), and endodontic treatment (intracanal preparation).

Regulatory Classification

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.

Submission Summary (Full Text)

{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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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
- 1. preparation of the osteotomy site
- 2. bone recontouring, osteoplasty
- B. Bone grafting
- 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
- 2. harvesting autogen living bone
- 3. 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
- 1. bone recontouring & alveoplasty around living teeth
- 2. 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)