510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941431Substantially Equivalent

Bone Graft Delivery Syringes

Bio-Interfaces, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941431 is the FDA 510(k) clearance record for BONE GRAFT DELIVERY SYRINGES, a class I device, cleared for Bio-Interfaces, Inc. on under FDA product code EID (Syringe, Restorative And Impression Material). FDA records list 17 510(k) clearances for Bio-Interfaces, Inc., from to . As of , FDA records show no recalls naming K941431.

Clearance record

Decision date
Received
(110 days to decision)
Product code
EID Syringe, Restorative And Impression Material
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Bio-Interfaces, Inc. 11095 Flintkote Ave., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code EID

Trailing 12 months

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

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