FDA.reportPublic FDA data

PERMASOFT

Primary DI
00842326102002
Brand
PERMASOFT
Company
The Myerson Company Limited
Model
PSKIT-60-PNK
Device description
60g KIT containing pink powder, liquid and sealer
Published
2021-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
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
00842326102002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842326102002008423261020028423261020020842326102002

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18004232683orders@myersontooth.com

Regulatory Flags#

DUNS number
857278431
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842326128095DuraflexDF-DPC-MD-6PK2026-05-26
00842326128101DuraflexDF-MPC-MD-6PK2026-05-26
00842326128118DuraflexDF-PNC-MD-6PK2026-05-26
00842326128125DuraflexDF-TTC-MD-6PK2026-05-26
00842326199620Trusana1TRUJR-U12025-10-24
00842326104693DuraflexDFDISC-NP-98-202025-09-04
00842326104709DuraflexDFDISC-NP-98-252025-09-04
00842326199460TrusanaTRU405-LTPNK-TRI2025-08-26
00842326199477TrusanaTRU405-DKPNK-TRI2025-08-26
00842326199484TrusanaTRU405-A1-N-TRI2025-08-26
00842326199491TrusanaTRU405-A2-N-TRI2025-08-26
00842326199507TrusanaTRU405-A3-N-TRI2025-08-26
00842326199514TrusanaTRU405-B1-N-TRI2025-08-26
00842326199521TrusanaTRU405-B2-N-TRI2025-08-26
00842326199538TrusanaTRU405-51-N-TRI2025-08-26
00842326104235VisiclearVCDISCB-98-152018-08-09
00842326104242VisiclearVCDISCB-98-202018-08-09
00842326199576Trusana1TRUJR-A12025-02-28
00842326199583Trusana1TRUJR-A22025-02-28
00842326199590Trusana1TRUJR-A32025-02-28

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Primary DI, Brand, Company table
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