Cleared Traditional

K834190 - JAKOBI SURG. INSTRUMENTS #8 15

K834190 is an FDA 510(k) clearance for JAKOBI SURG. INSTRUMENTS #8 15, manufactured by Imm Enterprises , Ltd.. The device is a Class 1 Dental device with product code EMH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K834190 · Imm Enterprises , Ltd. · Dental device
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Mar 1984
Decision
106d
Days
Class 1
Risk

K834190 is an FDA 510(k) clearance for the JAKOBI SURG. INSTRUMENTS #8 15. Classified as Forceps, Rongeur, Surgical (product code EMH), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1984 after a review of 106 days - within the typical 510(k) review window.

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: 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 Imm Enterprises , Ltd. devices

FDA 510(k) Submission Details - K834190

510(k) Number K834190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1983
Decision Date March 06, 1984
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

EMH Device Classification - Class 1, General Controls

Product Code EMH Forceps, Rongeur, 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 - EMH Forceps, Rongeur, Surgical

Devices cleared under the same product code (EMH) and FDA review panel - the closest regulatory comparables to K834190.
BONE RONGEUR, DOUBLE-ACTION
K890256 · Kinetic Medical Products · Jan 1989
MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT
K854887 · Walter Lorenz Surgical, Inc. · Feb 1986
586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC
K851710 · Artiberia · Jun 1985
MODIFIED RONGEURS FOR SPINAL & ORTH. S.
K821358 · Downs Surgical , Ltd. · May 1982
FORCEPS, STYLE #849
K771522 · Premier Dental Products Co. · Aug 1977