510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960164Substantially Equivalent

Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140

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

K960164 is the FDA 510(k) clearance record for BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140, a class II device, cleared for Bio-Interfaces, Inc. on under FDA product code LYC (Bone Grafting Material, Synthetic). FDA's definition for product code LYC reads: "A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw". FDA records list 17 510(k) clearances for Bio-Interfaces, Inc., from to . As of , FDA records show no recalls naming K960164.

Clearance record

Decision date
Received
(85 days to decision)
Product code
LYC Bone Grafting Material, Synthetic
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Bio-Interfaces, Inc. 11095 Flintkote Ave., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code LYC

Trailing 12 months
3 clearances under product code LYC in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LYC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260