Cleared Traditional

K000112 - ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401

K000112 is an FDA 510(k) clearance for ACUCAM CONCEPT IV, manufactured by Dentsply Intl.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K000112 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
90d
Days
Class 1
Risk

K000112 is an FDA 510(k) clearance for the ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10.... Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dentsply Intl. (Des Plaines, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K000112

510(k) Number K000112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2000
Decision Date April 13, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 184
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K000112.
4631 DUO DELIVERY SYSTEM
K000966 · A-Dec, Inc. · May 2000
4635 ASSISTANT'S INSTRUMENTATION
K000967 · A-Dec, Inc. · May 2000
3181 DUO DELIVERY SYSTEM
K000968 · A-Dec, Inc. · May 2000
QUANTEC-E IRRIGATION SYSTEM 2
K992195 · Sybron Dental Specialties, Inc. · Oct 1999
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE
K992893 · Mrlb Intl., Inc. · Sep 1999
DENTAPURE DP40 CARTRIDGE
K992868 · Mrlb Intl., Inc. · Sep 1999