510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K040646Substantially Equivalent

Straumann Granules

Straumann USA, LLC, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040646 is the FDA 510(k) clearance record for STRAUMANN GRANULES, a class II device, cleared for The Straumann Co. 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 176 510(k) clearances for Straumann USA, LLC, from to . As of , FDA records show no recalls naming K040646.

Clearance record

Decision date
Received
(53 days to decision)
Product code
LYC Bone Grafting Material, Synthetic
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
The Straumann Co. Reservoir Pl. 1601 Trapelo Rd., Waltham 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 November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LYC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260