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510(k) K963078

STERI-OSS TEMPORARY IMPLANT CEMENT by Steri-Oss, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1996
Date Received
August 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Steri-Oss, Inc.

  • K982400 — STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT (September 23, 1998)
  • K980439 — REPLACE CYLINDRICAL IMPLANTS (March 16, 1998)
  • 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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