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510(k) Data Aggregation
K Number
K980616Device Name
PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)
Manufacturer
Date Cleared
1998-04-30
(71 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
**KOHLER MEDIZINTECHNIK GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PERMAFIX is intended to permanently reline a denture surface that contacts tissue.
The product is self-curing and is intended for chairside use in dental practices and for dental laboratories. It is not intended for over-the-counter (OTC) use.
Applications
To avoid and to relieve pressure areas in the upper and lower denture
Post-damming of the A-line
Elastic cover for dentures in the upper jaw
Cushioning of overdentures that contact implants during the process of healing in the field of implantology
Device Description
PERMAFIX - Chairside Soft Denture Relining Device. The reliner remains permanently soft. Material: A-Silicone.
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