510(k) K791204
K791204 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "MITER ENDOSTEAL BLADE IMPLANT". The FDA issued a decision of Substantially Equivalent on Sep 28, 1979. The device falls under product code NRQ (Blade-Form Endosseous Dental Implant), a Class II device regulated under 21 CFR 872.3640. Depuy, Inc. has 302 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 1979
- Date Received
- Jun 28, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blade-Form Endosseous Dental Implant
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)
Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.