FDA.reportPublic FDA data

Preference Soft Denture Liner

Primary DI
D040200119303
Brand
Preference Soft Denture Liner
Company
WHIP-MIX CORPORATION
Model
Introduction Kit
Catalog number
20011930
Device description
ComfortSoft® is a high pressure cured, silicone-based soft lining material for long-term use in removable dentures. ComfortSoft® is suitable for all PMMA-based dentures, meets ISO 10139-2, and is a Shors A hardness Type A material.
Published
2016-09-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140146000COMFORTSOFT SOFT DENTURE LINER SYSTEMWhip Mix Corp.2014-04-29EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D040200119303PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture reliner, soft, professionalA denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
5026345357jwaters@whipmix.com

Regulatory Flags#

DUNS number
006385173
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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D04060004140Articulating paper/film60004600042020-08-17
D04060005144Articulating paper/film60005600052020-08-17
D04060006144Articulating paper/film60006600062020-08-17

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