Cleared Traditional

K980616 - PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)

K980616 is an FDA 510(k) clearance for PERMAFIX CHAIRSIDE SOFT DENTURE RELININ..., manufactured by Kohler Medizintechnik GmbH & Co. KG. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K980616 · Kohler Medizintechnik GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
71d
Days
Class 2
Risk

K980616 is an FDA 510(k) clearance for the PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15). Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Kohler Medizintechnik GmbH & Co. KG (Neuhausen, DE). The FDA issued a Cleared decision on April 30, 1998 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kohler Medizintechnik GmbH & Co. KG devices

FDA 510(k) Submission Details - K980616

510(k) Number K980616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1998
Decision Date April 30, 1998
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 219
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K980616.
LINER 1:HARD RELINE LIQUID
K981861 · Harry J. Bosworth Co. · Oct 1998
TOKUYAMA SOFRELINER
K982537 · Tokuyama America, Inc. · Aug 1998
KERR HARD DENTURE RELINE MATERIAL
K981448 · Sybron Dental Specialties, Inc. · Jun 1998
CSR
K974865 · Parkell, Inc. · Mar 1998
BRUXTRAK MATERIAL
K974160 · Bruxcare, LLC · Mar 1998
JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR
K974727 · J.B.C and Co. · Feb 1998