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510(k) K964944

ROUND DENTAL BUR by Steri-Oss, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1997
Date Received
December 10, 1996
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 Steri-Oss, Inc.

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  • K973433 — STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT (December 5, 1997)
  • K973423 — STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT (December 5, 1997)
  • K973402 — STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM (November 26, 1997)
  • K972965 — STERI-OSS UNTIL IMPLANT CEMENT (November 7, 1997)
  • K970073 — BIO-ESTHETIC INDIRECT ABUTMENT (July 3, 1997)
  • K964739 — STERI-OSS TIODIZED SCREW (March 31, 1997)
  • K964220 — REPLACE TITANIUM IMPLANT SYSTEM (March 5, 1997)
  • K963945 — STERI-OSS GOLD ATTACHMENT SYSTEM (February 11, 1997)

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