Cleared Traditional

BIO-C REPAIR (K180185) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180185 · Angelus Industria DE Produtos Odontologicos S/A · Dental device
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Aug 2018
Decision
220d
Days
Class 2
Risk

K180185 is an FDA 510(k) clearance for the BIO-C REPAIR. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Angelus Industria DE Produtos Odontologicos S/A (Londrina, BR). The FDA issued a Cleared decision on August 31, 2018 after a review of 220 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Angelus Industria DE Produtos Odontologicos S/A devices

Submission Details

510(k) Number K180185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2018
Decision Date August 31, 2018
Days to Decision 220 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
93d slower than avg
Panel avg: 127d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KIF Resin, Root Canal Filling

All 58
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K180185.
MTA2.3 MATERIALS
K181917 · NuSmile, Ltd. · Jan 2019
BIO-C TEMP
K180199 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2019
Sonendo Material A
K181922 · Sonendo, Inc. · Oct 2018
ENDOSEAL MTA
K170175 · Maruchi · Feb 2018
ENDOSOLV
K172839 · Septodont · Feb 2018
BIO-C SEALER
K172701 · Angelus Industria DE Produtos Odontologicos S/A · Jan 2018