SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD

K984508 · W&H Dentalwerk Buermoos GmbH · DZA · Jun 25, 1999 · Dental

Device Facts

• Record ID: K984508
• Device Name: SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
• Applicant: W&H Dentalwerk Buermoos GmbH
• Product Code: DZA · Dental
• Decision Date: Jun 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4130
• 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

Surgical contra-angle and straight handpieces used by dental professionals in oral surgery and endodontic procedures. Devices facilitate mechanical cutting, drilling, and shaping of bone and tooth structures; also used for intracanal preparation with NiTi-files. Operated by dentists/oral surgeons in clinical settings. Handpieces connect to dental motor systems to provide rotational power for surgical burs or endodontic instruments. Benefit includes precise bone/tooth removal and preparation for implants or restorative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical dental handpieces (contra-angle and straight). Powered by dental motor systems. Used for surgical and endodontic applications. No software or electronic components.

Indications for Use

Indicated for oral surgery procedures including implant site preparation, bone grafting, tooth/bone sectioning, periodontal surgery, and endodontic treatment using rotating NiTi-files.

Regulatory Classification

Identification

An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

Herbert Traschwandtner Mr. W&H Dentalwerk Buermoos GmbH 53 Iqnaz Glaser Strasse A-5111 Buermoos AUSTRIA

Re : K984508 Trade Name: Surgical Contra-Angle Handpieces, Models 975 AE, 979 E/KM, 985 AE, 986 AE, 988 E/KM Regulatory Class: I Product Code: DZA Dated: March 24, 1999 Received: March 29, 1999

Dear Mr. Traschwandtner:

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 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. ಕ್ಕೆ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Traschwandtner

Please note: this response to your premarket notification submission does 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 regulations.

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 [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 qeneral 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

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): K984508

Surgical Contra-Angle Handpieces Types 975 AE. 979 E/KM. 985 AE. DEVICE NAME: 986 AE, 988 E/KM Surgical Straight Handpieces Types S 11, SL 11

## INDICATIONS 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)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Reseller w/ Shipping (for MSR)

(Division Sign-Off Division of Dental, Info and General Hospits 51 O(k) Number