Cleared Traditional

K950511 - BLL-FIL 6140 PARTICLES

K950511 is an FDA 510(k) clearance for BLL-FIL 6140 PARTICLES, 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 80-day FDA review.

K950511 · Bio-Interfaces, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
80d
Days
Class 2
Risk

K950511 is an FDA 510(k) clearance for the BLL-FIL 6140 PARTICLES. 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 April 27, 1995 after a review of 80 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.

View all Bio-Interfaces, Inc. devices

FDA 510(k) Submission Details - K950511

510(k) Number K950511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date April 27, 1995
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
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 K950511.
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
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K943186 · Lifecore Biomedical, Inc. · Apr 1995
RESOLUT REGENERATIVE MATERIAL
K932866 · W.L. Gore & Associates, Inc. · Mar 1995
INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS
K950165 · Interpore Intl. · Mar 1995