510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031813Substantially Equivalent

Ossatura Dental

Isotis NV, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031813 is the FDA 510(k) clearance record for OSSATURA DENTAL, a class II device, cleared for Isotis NV 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 8 510(k) clearances for Isotis NV, from to . As of , FDA records show no recalls naming K031813.

Clearance record

Decision date
Received
(435 days to decision)
Product code
LYC Bone Grafting Material, Synthetic
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Isotis NV 49 Plain St., North Attleboro MA
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