510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954690Substantially Equivalent

Stryker Oral Max System

Stryker Corp., Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954690 is the FDA 510(k) clearance record for STRYKER ORAL MAX SYSTEM, a class II device, cleared for Stryker Corp. on under FDA product code DZI (Drill, Bone, Powered). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show no recalls naming K954690.

Clearance record

Decision date
Received
(314 days to decision)
Product code
DZI Drill, Bone, Powered
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Stryker Corp. 2725 Fairfield Rd., Kalamazoo MI
510(k) summary
Summary
Third party review
No

Clearances, product code DZI

Trailing 12 months
3 clearances under product code DZI in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZI, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260
November 20260