Cleared Traditional

K011698 - STRAUMANN GBR SYSTEM

K011698 is an FDA 510(k) clearance for STRAUMANN GBR SYSTEM, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K011698 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
83d
Days
Class 2
Risk

K011698 is an FDA 510(k) clearance for the STRAUMANN GBR SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Institut Straumann AG (Waltham, US). The FDA issued a Cleared decision on August 23, 2001 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Institut Straumann AG devices

FDA 510(k) Submission Details - K011698

510(k) Number K011698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2001
Decision Date August 23, 2001
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K011698.
THE BIOPLATE MANDIBLE FIXATION SYSTEM
K012910 · Bioplate, Inc. · Nov 2001
INION CPS 2.0 ORTHOGNATHIC PLATE
K013039 · Inion , Ltd. · Oct 2001
MACROPORE FX, PS, NS, LP
K012413 · Macropore Biosurgery, Inc. · Sep 2001
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc. · Aug 2001
MACROPOREPX PEDIATRIC SYSTEM
K002207 · Macropore Biosurgery, Inc. · Jul 2001
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K011380 · Bioplate, Inc. · May 2001