FDA.reportPublic FDA data

Infinity®

Primary DI
D81380000
Brand
Infinity®
Company
DEN-MAT HOLDINGS, LLC
Model
8000
Catalog number
8000
Device description
SOLVENEX 8oz
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZPSolution, Cement Disolving

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZPSolution, Cement DissolvingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K771974000SOLVENEX I-0Den-Mat Corp.1978-01-12KZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D81380000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06
00359883007218EVANESCE0322200322202025-10-08
00359883005214Max Etch 35% Phosphoric Acid Etch 30mL3453023453022025-03-12
00359883005221Max Etch 35% Phosphoric Acid Etch 5mL3455033455032025-03-12
D8130301255000Ceri-Prime0301255000301255002016-09-24
D8130304025501Cerinate®0304025500304025502016-09-24
D8131002AB0Ceri-Prime1002AB1002AB2016-09-24
D8131398B0Ceri-Prime1398B1398B2016-09-24
D81313990Ceri-Prime139913992016-09-24
D813402022B0Other402022B402022B2016-09-24
D8134020600Ceri-Prime4020604020602016-09-24
D81340213100Ceri-Prime402131040213102016-09-24
00359883007201EVANESCE0322550322552025-05-30
00359883005665Tissue Goo™ Hemostatic Gel 4-Pack6419046419042025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit6419606419602025-03-18
00359883002053Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883002046Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883006273Final Shine Cotton Polishing Wheel 50-Pack1335001335002025-03-13
00359883006501Clinician's Choice® G5 Sample Pack9726059726052025-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8130307550000Dry-BondDEN-MAT HOLDINGS, LLCKZP2016-09-24
D81375000Dry-BondDEN-MAT HOLDINGS, LLCKZP2016-09-24
D81375250Dry-BondDEN-MAT HOLDINGS, LLCKZP2016-09-24
D81375500Dry-BondDEN-MAT HOLDINGS, LLCKZP2016-09-24