Cleared Traditional

K881924 - ENDOSSEOUS DENTAL IMPLANT

K881924 is an FDA 510(k) clearance for ENDOSSEOUS DENTAL IMPLANT, manufactured by Bone Anchorage Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K881924 · Bone Anchorage Systems, Inc. · Dental device
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Jun 1988
Decision
35d
Days
Class 2
Risk

K881924 is an FDA 510(k) clearance for the ENDOSSEOUS DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Bone Anchorage Systems, Inc. (Toronto, Canada, CA). The FDA issued a Cleared decision on June 13, 1988 after a review of 35 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 Bone Anchorage Systems, Inc. devices

FDA 510(k) Submission Details - K881924

510(k) Number K881924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1988
Decision Date June 13, 1988
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 128d · This submission: 35d
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 1330
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K881924.
SURGICAL DRILLS
K891615 · Implant Innovations International, Inc. · Apr 1989
TITANIUM FORCEPS
K891618 · Implant Innovations International, Inc. · Apr 1989
IMZ O-RING ATTACHMENT
K883211 · Interpore Intl. · Nov 1988
INNOVATIVE IMPLANTS AND COVER SCREWS
K874590 · Implant Innovations International, Inc. · May 1988
THE MICRO-VENT/HA
K873255 · Core-Vent Corp. · Mar 1988
NON-ROTATING GOLD CYLINDER AND SCREW
K874400 · Implant Innovations International, Inc. · Mar 1988