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510(k) K963897

STERI-OSS SINUS AUGMENTATION KIT by Steri-Oss, Inc. — Product Code EMM

K963897 is an FDA 510(k) premarket notification submitted by Steri-Oss, Inc. for the device "STERI-OSS SINUS AUGMENTATION KIT". The FDA issued a decision of Substantially Equivalent on November 6, 1996. The device falls under product code EMM (Chisel, Osteotome, Surgical), a Class I device regulated under 21 CFR 872.4565. Steri-Oss, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1996
Date Received
September 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chisel, Osteotome, Surgical
Device Class
Class I
Regulation Number
872.4565
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)

Other clearances for product code EMM

  • K864775 — CHISEL (OSTEOTOME, GOUGE, ETC.) (February 12, 1987)
  • K851714 — 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS (June 11, 1985)
  • K760959 — SURGICAL CHISEL (November 15, 1976)

FDA data resources