510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102015Substantially Equivalent

Osteon, Osteon Sinus, Osteon Lifting

GENOSS Co., Ltd., Cypress CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102015 is the FDA 510(k) clearance record for OSTEON, OSTEON SINUS, OSTEON LIFTING, a class II device, cleared for Genoss Co., Ltd. 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 23 510(k) clearances for Genoss Co., Ltd., from to . As of , FDA records show no recalls naming K102015.

Clearance record

Decision date
Received
(126 days to decision)
Product code
LYC Bone Grafting Material, Synthetic
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Genoss Co., Ltd. 11075 Knott Ave., Suite A, Cypress CA
510(k) summary
Summary PDF
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