Cleared Traditional

K130436 - MULTILINK HYBRID ABUTMENT CEMENT

K130436 is an FDA 510(k) clearance for MULTILINK HYBRID ABUTMENT CEMENT, manufactured by Ivoclar Vivadent, AG. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K130436 · Ivoclar Vivadent, AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
180d
Days
Class 2
Risk

K130436 is an FDA 510(k) clearance for the MULTILINK HYBRID ABUTMENT CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on August 20, 2013 after a review of 180 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 Ivoclar Vivadent, AG devices

FDA 510(k) Submission Details - K130436

510(k) Number K130436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2013
Decision Date August 20, 2013
Days to Decision 180 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
53d slower than avg
Panel avg: 127d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 421
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