Cleared Traditional

K982111 - VARIOUS DENTAL IMPLANTS

K982111 is an FDA 510(k) clearance for VARIOUS DENTAL IMPLANTS, manufactured by Biotech Medical Instruments Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K982111 · Biotech Medical Instruments Corp. · Dental device
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Sep 1998
Decision
91d
Days
Class 2
Risk

K982111 is an FDA 510(k) clearance for the VARIOUS DENTAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biotech Medical Instruments Corp. (Marion, US). The FDA issued a Cleared decision on September 15, 1998 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Biotech Medical Instruments Corp. devices

FDA 510(k) Submission Details - K982111

510(k) Number K982111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1998
Decision Date September 15, 1998
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
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 940
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K982111.
FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476
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K980083 · Implant Innovations, Inc. · Aug 1998
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K974106 · Bio Science Technologies, Inc. · Jun 1998