Cleared Traditional

K840312 - CAT. 8 DENTAL DEVICES

K840312 is an FDA 510(k) clearance for CAT. 8 DENTAL DEVICES, manufactured by Imm Enterprises , Ltd.. The device is a Class 1 Dental device with product code EMG cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K840312 · Imm Enterprises , Ltd. · Dental device
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Apr 1984
Decision
72d
Days
Class 1
Risk

K840312 is an FDA 510(k) clearance for the CAT. 8 DENTAL DEVICES. Classified as Forceps, Tooth Extractor, Surgical (product code EMG), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Imm Enterprises , Ltd. devices

FDA 510(k) Submission Details - K840312

510(k) Number K840312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date April 05, 1984
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

EMG Device Classification - Class 1, General Controls

Product Code EMG Forceps, Tooth Extractor, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EMG Forceps, Tooth Extractor, Surgical

All 7
Devices cleared under the same product code (EMG) and FDA review panel - the closest regulatory comparables to K840312.
600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE
K851711 · Artiberia · Jun 1985
600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI
K851712 · Artiberia · Jun 1985
TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/
K851105 · The Huxley Instrument Corp. · May 1985
DENTAL INSTRUMENTS - SURGICAL FORCEPS
K823325 · Miltex, Inc. · Nov 1982
BEACH FORCEP NO. 150 AND NO. 151
K821781 · Pacific Dental Corp. · Jul 1982