510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914892Substantially Equivalent

Saliva-Stim

Orion Diagnostica, Inc., 02101 Espoo, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914892 is the FDA 510(k) clearance record for SALIVA-STIM, a class I device, cleared for Orion Diagnostica, Inc. on under FDA product code EGD (Wax, Dental, Intraoral). FDA records list 32 510(k) clearances for Orion Diagnostica, Inc., from to . As of , FDA records show no recalls naming K914892.

Clearance record

Decision date
Received
(307 days to decision)
Product code
EGD Wax, Dental, Intraoral
Regulation
21 CFR 872.6890
Device class
Class I
Review panel
Dental
Applicant
Orion Diagnostica, Inc. P.O. Box 83, 02101 Espoo, FI
510(k) summary
Statement
Third party review
No

Clearances, product code EGD

Trailing 12 months

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

FDA records show no clearances under product code EGD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EGD, 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