Cleared Traditional

K101104 - REMIN PRO

K101104 is an FDA 510(k) clearance for REMIN PRO, manufactured by Voco GmbH. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K101104 · Voco GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
184d
Days
Class 1
Risk

K101104 is an FDA 510(k) clearance for the REMIN PRO. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on October 21, 2010 after a review of 184 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 Voco GmbH devices

FDA 510(k) Submission Details - K101104

510(k) Number K101104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2010
Decision Date October 21, 2010
Days to Decision 184 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
57d slower than avg
Panel avg: 127d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

EJR Device Classification - Class 1, General Controls

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
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 - EJR Agent, Polishing, Abrasive, Oral Cavity

All 35
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K101104.
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ENAMEL PRO
K062166 · Premier Dental Products Co. · Nov 2006
MI PASTE
K042200 · GC America, Inc. · Oct 2004