Cleared Traditional

K912473 - ACCU-PLACER TM KIT

K912473 is an FDA 510(k) clearance for ACCU-PLACER TM KIT, manufactured by Hu-Friedy Mfg. Co., Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K912473 · Hu-Friedy Mfg. Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
50d
Days
Class 1
Risk

K912473 is an FDA 510(k) clearance for the ACCU-PLACER TM KIT. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Hu-Friedy Mfg. Co., Inc. (Chicago, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 50 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 Hu-Friedy Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K912473

510(k) Number K912473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1991
Decision Date July 24, 1991
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

EKJ Device Classification - Class 1, General Controls

Product Code EKJ Burnisher, Operative
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 - EKJ Burnisher, Operative

All 21
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K912473.
APPLICATOR NOZZLE
K926368 · Centrix, Inc. · Sep 1993
PART 872 DEGUFILL H & DEGUFILL M DA
K914368 · Degussa AG · Nov 1991
IMPLARETTE
K911655 · Implant Innovations International, Inc. · Oct 1991
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991
PULPDENT PIC N STIC
K911281 · Pulpdent Corp. · May 1991
MIRROR SHIELD
K901053 · Pulpdent Corp. · May 1990