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510(k) K981954

VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS by Healthline Implants, Inc. — Product Code NRQ

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 January 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
January 25, 1999
Date Received
June 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

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.

Other clearances for product code NRQ

  • K211872 — PiezoImplant System (October 12, 2022)
  • K822969 — GENERATION 5 LINKOW BLADE IMPLANTS (November 4, 1982)
  • K791366 — ORATRONICS ENDOSSEOUS FRAME ASSEMBLY (October 9, 1979)
  • K791204 — MITER ENDOSTEAL BLADE IMPLANT (September 28, 1979)

FDA data resources