Cleared Traditional

K100247 - DETAX IMPLANTLINK SEMI

K100247 is the FDA 510(k) clearance for DETAX IMPLANTLINK SEMI by Detax GmbH & Co. KG. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K100247 · Detax GmbH & Co. KG · Dental device
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Jul 2010
Decision
177d
Days
Class 2
Risk

K100247 is an FDA 510(k) clearance for the DETAX IMPLANTLINK SEMI. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Detax GmbH & Co. KG (Amsterdam, NL). The FDA issued a Cleared decision on July 23, 2010 after a review of 177 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Detax GmbH & Co. KG devices

Submission Details

510(k) Number K100247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2010
Decision Date July 23, 2010
Days to Decision 177 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
50d slower than avg
Panel avg: 127d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 255
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IONOLUX
K090817 · Voco GmbH · Jul 2009
EQUIA
K091106 · GC America, Inc. · Jun 2009