510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963897Substantially Equivalent

Steri-Oss Sinus Augmentation Kit

Steri-Oss, Inc., Yorba Linda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963897 is the FDA 510(k) clearance record for STERI-OSS SINUS AUGMENTATION KIT, a class I device, cleared for Steri-Oss, Inc. on under FDA product code EMM (Chisel, Osteotome, Surgical). FDA records list 46 510(k) clearances for Steri-Oss, Inc., from to . As of , FDA records show no recalls naming K963897.

Clearance record

Decision date
Received
(40 days to decision)
Product code
EMM Chisel, Osteotome, Surgical
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Steri-Oss, Inc. 22895 Eastpark Dr., Yorba Linda CA
510(k) summary
Statement
Third party review
No

Clearances, product code EMM

Trailing 12 months

FDA records hold no clearances under product code EMM in the trailing twelve months.

FDA records show no clearances under product code EMM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EMM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260