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510(k) K883373

STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT by Denar Corp. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1989
Date Received
August 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Denar Corp.

  • K925705 — ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM (December 28, 1992)
  • K924759 — COLLIMATOR LIGHT SOURCE (December 9, 1992)
  • K884845 — STERI-OSS (February 10, 1989)
  • K852802 — DENAR DENTAL IMPLANT (September 23, 1985)

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