(189 days)
Indications are very widespread in the field of oral surgery ranging from
- A. Implant placement, including
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- preparation of the osteotomy site
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- bone recontouring, osteoplasty
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- B. Bone grafting
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- Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
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- harvesting autogen living bone
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- sinus elevation & grafting of alveolar sockets
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- C. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
- D. Periodontal surgeries
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- bone recontouring & alveoplasty around living teeth
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- removal of exostosis
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- E. Endodontic treatment
Intracanal preparations using rotating NiTi-files.
Surgical Contra-Angle Handpieces Types 975 AE. 979 E/KM. 985 AE. 986 AE, 988 E/KM Surgical Straight Handpieces Types S 11, SL 11
This document is a 510(k) clearance letter from the FDA for several models of "Surgical Contra-Angle Handpieces" and "Surgical Straight Handpieces." It declares the devices "substantially equivalent" to predicate devices, allowing them to be marketed.
Crucially, this document is an approval letter, not a study report. It does not contain any information about acceptance criteria or the study that proves the device meets those criteria.
The letter explicitly states:
"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..."
This means the device was cleared based on a demonstration of substantial equivalence to a legally marketed predicate device, rather than through a new clinical trial or performance study against specific acceptance criteria.
Therefore, I cannot provide the requested information from this document. The document simply confirms the FDA's decision to allow the devices to be marketed.
§ 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.