510(k) K981954
K981954 is an FDA 510(k) premarket notification submitted by Healthline Implants, Inc. for the device "VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS". The FDA issued a decision of Substantially Equivalent on Jan 25, 1999. The device falls under product code NRQ (Blade-Form Endosseous Dental Implant), a Class II device regulated under 21 CFR 872.3640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 25, 1999
- Date Received
- Jun 4, 1998
- 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.