FDA.reportPublic FDA data

PermaSoft®

Primary DI
D001N8115000
Brand
PermaSoft®
Company
Dentsply International Inc.
Model
Soft Denture Liner Combination Kit
Catalog number
N811500
Device description
Contains one (1) 60 gram powder (Pink), one (1) 30 gram powder (Clear), one (1) 60 milliliter liquid, and one (1) 30 milliliter sealer
Published
2017-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K933468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933468000MYERSON'S PERMASOFT SOFT RELINE MATERIALAustenal, Inc.1994-01-05EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D001N8115000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)243-1942Prosthetics-Regulatory@dentsplysirona.com

Regulatory Flags#

DUNS number
606173334
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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