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510(k) K972965

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1997
Date Received
August 11, 1997
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)
  • K973423 — STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT (December 5, 1997)
  • K973433 — STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT (December 5, 1997)
  • K973402 — STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM (November 26, 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)
  • K964944 — ROUND DENTAL BUR (February 10, 1997)

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