Cleared Traditional

K902968 - BIO-VENT-X ENDOSSEOUS HA COATED DENTAL ...

K902968 is an FDA 510(k) clearance for BIO-VENT-X ENDOSSEOUS HA COATED DENTAL ..., manufactured by Core-Vent Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K902968 · Core-Vent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
313d
Days
Class 2
Risk

K902968 is an FDA 510(k) clearance for the BIO-VENT-X ENDOSSEOUS HA COATED DENTAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Core-Vent Corp. (Encino, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Core-Vent Corp. devices

FDA 510(k) Submission Details - K902968

510(k) Number K902968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1990
Decision Date May 15, 1991
Days to Decision 313 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 127d · This submission: 313d
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 758
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K902968.
BRANEMARK SYSTEM-5.0MM FIXTURE
K911961 · Nobelpharma USA, Inc. · Jul 1991
HH-1119 HEALING HEAD
K903515 · Minimatic Implant Technology · Jul 1991
DEVICE PART NUMBERS: - 1400 SERIES
K911112 · Minimatic Implant Technology · Jun 1991
BC 1208 IMPLANT, THREADED EXTERNAL HEX
K904707 · Minimatic Implant Technology · Apr 1991
IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER
K905039 · Minimatic Implant Technology · Apr 1991
ICT-1108 IMPLANT- THREADED (CEMENT TYPE ABUTMENT)
K903043 · Minimatic Implant Technology · Apr 1991