(189 days)
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No
The document describes surgical handpieces and their intended uses in oral surgery. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities typically associated with AI/ML in medical devices.
No.
This device is described as surgical contra-angle and straight handpieces, which are instruments used to perform surgical procedures, not to provide therapy.
No.
The device description indicates it is a "Surgical Contra-Angle Handpieces" and "Surgical Straight Handpieces," which are used for surgical procedures like bone recontouring, implant placement, and tooth removal, not for diagnosing conditions.
No
The device description explicitly lists "Surgical Contra-Angle Handpieces" and "Surgical Straight Handpieces," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "Surgical Contra-Angle Handpieces" and "Surgical Straight Handpieces" used for various procedures within the oral cavity (implant placement, bone grafting, tooth removal, periodontal surgeries, endodontic treatment). These are surgical tools used directly on the patient's body, not for testing samples outside the body.
The intended use and device description are consistent with a surgical instrument, not an IVD.
N/A
Intended Use / Indications 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.
Product codes
DZA
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 872.4130 Intraoral dental drill.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
1
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 (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" (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 (800) 638-2041 or (301) 443-6597 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
2
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
-
- 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)
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