FDA.reportPublic FDA data

Permlastic

Primary DI
00195062144417
Brand
Permlastic
Company
Kerr Corporation
Model
00674
Device description
RUBBER BASE ADHESIVE 2oz
Published
2026-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003650000PERMLASTIC 3Sybron Dental Specialties, Inc.2001-02-15ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195062144417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195062144417001950621444171950621444170195062144417

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage Environment Temperature: between 15 and 25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-537-7123kerrcustcare@kavokerr.com

Regulatory Flags#

DUNS number
199354556
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195062153846NeoFil346652026-11-04
00195062164606FibrekorN182026-11-04
00195062164613FibrekorN18A2026-11-04
00195062160110NX3336422026-10-29
00195062164422OptiGuard258802026-10-29
00195062164439OptiGuard266852026-10-29
10841396117883Optidisc334752026-10-29
00195062159787BreezeN97E2026-10-27
00195062159794Breeze RMGIN982026-10-27
00195062160332Build-It FRN32AA2026-10-27
00195062160349Build-It FRN32AB2026-10-27
00195062160356Build-It FRN32AC2026-10-27
00195062160363Build-It FRN32AD2026-10-27
00195062160370Build-It FRN32AE2026-10-27
00195062160387Build-It FRN32FS2026-10-27
00195062160394Build-It FRN32FSA2026-10-27
00195062160400Build-It FRN32FSB2026-10-27
00195062160417Build-It FRN32FSC2026-10-27
00195062160424Build-It FRN32FSD2026-10-27
00195062160431Build-It FRN32FA2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412304789Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313163Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313170Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313187Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06970402679941Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06970402679958Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
00197998040627Solventum™ Paradigm™Solventum US LLCELW2026-10-24
00197998040733Solventum™ Paradigm™Solventum US LLCELW2026-10-24
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20