Cleared Traditional

K934049 - BII-PORE(TM) CANAL WALL PROSTHESIS

K934049 is an FDA 510(k) clearance for BII-PORE(TM) CANAL WALL PROSTHESIS, manufactured by Bio-Interfaces, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K934049 · Bio-Interfaces, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
334d
Days
Class 2
Risk

K934049 is an FDA 510(k) clearance for the BII-PORE(TM) CANAL WALL PROSTHESIS. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Bio-Interfaces, Inc. (San Diego, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 334 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Interfaces, Inc. devices

FDA 510(k) Submission Details - K934049

510(k) Number K934049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1993
Decision Date July 19, 1994
Days to Decision 334 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
207d slower than avg
Panel avg: 127d · This submission: 334d
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 122
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K934049.
OSTEOGRAF/D-100 HYDROXYLAPATITE
K942946 · Ceramed Corp. · Oct 1994
OSTEOGRAF/LD-300 HYDROXYLAPATITE
K942212 · Ceramed Corp. · Aug 1994
BII-PORE
K933688 · Bio-Interfaces, Inc. · Jul 1994
BON APATITE HA PARTICLES
K934430 · Bio-Interfaces, Inc. · May 1994
BII-PLAST
K934947 · Bio-Interfaces, Inc. · Jan 1994
710 POROUS HA PARTICLES-BII-PORE
K924287 · Bio-Interfaces, Inc. · Apr 1993