Cleared Traditional

K981881 - DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981881 · Doctor'S Research Group, Inc. · Dental device
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Dec 1998
Decision
188d
Days
Class 2
Risk

K981881 is an FDA 510(k) clearance for the DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF D.... Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Doctor'S Research Group, Inc. (Wolcott, US). The FDA issued a Cleared decision on December 2, 1998 after a review of 188 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 Doctor'S Research Group, Inc. devices

Submission Details

510(k) Number K981881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1998
Decision Date December 02, 1998
Days to Decision 188 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
61d slower than avg
Panel avg: 127d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 79
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