Cleared Traditional

K040646 - STRAUMANN GRANULES

K040646 is an FDA 510(k) clearance for STRAUMANN GRANULES, manufactured by The Straumann Co.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K040646 · The Straumann Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
53d
Days
Class 2
Risk

K040646 is an FDA 510(k) clearance for the STRAUMANN GRANULES. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by The Straumann Co. (Waltham, US). The FDA issued a Cleared decision on May 3, 2004 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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.

FDA 510(k) Submission Details - K040646

510(k) Number K040646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2004
Decision Date May 03, 2004
Days to Decision 53 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
75d faster than avg
Panel avg: 128d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYC Device Classification - Class 2, Special Controls

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition 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.
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 - LYC Bone Grafting Material, Synthetic

All 217
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K040646.
OSSATURA DENTAL
K031813 · Isotis NV · Aug 2004
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER
K041324 · Lifecore Biomedical, Inc. · Jul 2004
BBP BONE SUBSTITUTES
K030195 · Oct, USA, Inc. · Jun 2004
OSTEOGEN SBRG
K033098 · Impladent , Ltd. · Apr 2004
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
K033994 · Novabone Products, LLC · Mar 2004
COLLAGEN DENTAL WOUND DRESSINGS
K033729 · Collagen Matrix, Inc. · Mar 2004
K040646 · STRAUMANN GRANULES
Download PDF FDA Summary The Straumann Co.