Cleared Traditional

K913651 - MANI DIA-BURS

K913651 is an FDA 510(k) clearance for MANI DIA-BURS, manufactured by The Lahr Consulting Group, Inc.. The device is a Class 1 Dental device with product code DZP cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K913651 · The Lahr Consulting Group, Inc. · Dental device
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Jan 1992
Decision
151d
Days
Class 1
Risk

K913651 is an FDA 510(k) clearance for the MANI DIA-BURS. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by The Lahr Consulting Group, Inc. (Mahwah, US). The FDA issued a Cleared decision on January 14, 1992 after a review of 151 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4535 - 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 The Lahr Consulting Group, Inc. devices

FDA 510(k) Submission Details - K913651

510(k) Number K913651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1991
Decision Date January 14, 1992
Days to Decision 151 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
24d slower than avg
Panel avg: 127d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

DZP Device Classification - Class 1, General Controls

Product Code DZP Instrument, Diamond, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4535
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DZP Instrument, Diamond, Dental

Devices cleared under the same product code (DZP) and FDA review panel - the closest regulatory comparables to K913651.
BLUWHITE DIAMOND DENTAL BURS MODIFIED
K120037 · Beavers Dental, Div. Sybron Canada, Ltd. · Apr 2012
DENDIA WERK BURS AND CUTTING DISCS
K901967 · Micro-Aire Surgical Instruments, Inc. · Jul 1990
HYBRID POINTS
K854347 · Shofu Dental Corp. · Dec 1985
GINGI CURETTAGE DIAMOND POINTS
K832856 · Shofu Dental Corp. · Oct 1983
SUMMA DISK
K833038 · Shofu Dental Corp. · Oct 1983
TPE DIAMOND POINTS
K832855 · Shofu Dental Corp. · Sep 1983