Cleared Traditional

K895854 - ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)

K895854 is an FDA 510(k) clearance for ACME PREFORMED COATED LIGATURE TIES (TO..., manufactured by Acme-Monaco Corp.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K895854 · Acme-Monaco Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
188d
Days
Class 1
Risk

K895854 is an FDA 510(k) clearance for the ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE). Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Acme-Monaco Corp. (Plainville, US). The FDA issued a Cleared decision on April 9, 1990 after a review of 188 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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.

FDA 510(k) Submission Details - K895854

510(k) Number K895854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date April 09, 1990
Days to Decision 188 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
60d slower than avg
Panel avg: 128d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

EJF Device Classification - Class 1, General Controls

Product Code EJF Bracket, Metal, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
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 - EJF Bracket, Metal, Orthodontic

All 102
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K895854.
FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)
K900824 · Midwest Orthodontic Mfg. · May 1990
STAINLESS STEEL DENTAL WIRES AND CLASPS
K901024 · Ivoclar North America, Inc. · Apr 1990
SPORTS PACK ELASTICS
K900578 · Lancer Orthodontics, Inc. · Apr 1990
LINGUAL SHEATH
K900184 · Ormco Corp. · Apr 1990
ACME COATED ORTHODONTIC ARCHWIRE
K895483 · Acme-Monaco Corp. · Jan 1990
UNI-STICK PLASTIC LIGATURES
K891331 · American Orthodontics · Oct 1989
K895854 · ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)
Download PDF Acme-Monaco Corp.