Cleared Traditional

K951937 - BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM)

K951937 is an FDA 510(k) clearance for BIOPATH SELF-TAPPING DENTAL IMPLANT SYS..., manufactured by Bio Path. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K951937 · Bio Path · Dental device
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Jun 1995
Decision
41d
Days
Class 2
Risk

K951937 is an FDA 510(k) clearance for the BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Bio Path (Lake Tahoe, US). The FDA issued a Cleared decision on June 5, 1995 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Path devices

FDA 510(k) Submission Details - K951937

510(k) Number K951937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1995
Decision Date June 05, 1995
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1319
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K951937.
TORQUE LIMITER
K952120 · Steri-Oss, Inc. · Jun 1995
3.3MM ACCESSORIES
K952448 · Nobelpharma USA, Inc. · Jun 1995
SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS
K951065 · Steri-Oss, Inc. · Jun 1995
OSTEOTOMES
K952193 · Steri-Oss, Inc. · Jun 1995
INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM
K944327 · Calcitek, Inc. · May 1995
INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING
K941608 · Calcitek, Inc. · May 1995