Cleared Traditional

K924408 - COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE

K924408 is an FDA 510(k) clearance for COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE, manufactured by Colla-Tec, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 1085-day FDA review.

K924408 · Colla-Tec, Inc. · Dental device
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Aug 1995
Decision
1085d
Days
Class 2
Risk

K924408 is an FDA 510(k) clearance for the COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Colla-Tec, Inc. (Plainsboro, US). The FDA issued a Cleared decision on August 22, 1995 after a review of 1085 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Colla-Tec, Inc. devices

FDA 510(k) Submission Details - K924408

510(k) Number K924408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date August 22, 1995
Days to Decision 1085 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
958d slower than avg
Panel avg: 127d · This submission: 1085d
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 181
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K924408.
BIO-OSS
K952618 · Geistlich-Pharma · Aug 1995
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K952619 · Geistlich-Pharma · Aug 1995
BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT
K950598 · Bio-Interfaces, Inc. · Aug 1995
BIO-OSS
K952617 · Geistlich-Pharma · Aug 1995
BIO-APATITE 6140 HA PARTICLES
K950567 · Bio-Interfaces, Inc. · May 1995
BLL-FIL 6140 PARTICLES
K950511 · Bio-Interfaces, Inc. · Apr 1995