510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K011698Substantially Equivalent

Straumann Gbr System

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

K011698 is the FDA 510(k) clearance record for STRAUMANN GBR SYSTEM, a class II device, cleared for Institut Straumann AG on under FDA product code JEY (Plate, Bone). FDA records list 176 510(k) clearances for Straumann USA, LLC, from to . As of , FDA records show no recalls naming K011698.

Clearance record

Decision date
Received
(83 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Institut Straumann AG Reservoir Pl. 1601 Trapelo Rd., Waltham MA
510(k) summary
Summary
Third party review
No

Clearances, product code JEY

Trailing 12 months
4 clearances under product code JEY in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260
November 20260