FDA.reportPublic FDA data

Dry-Bond

Primary DI
D81375000
Brand
Dry-Bond
Company
DEN-MAT HOLDINGS, LLC
Model
7500
Catalog number
7500
Device description
DRY-BOND 240mL
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
D81375000PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Do not expose to source of ignition or open flame
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

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
Manufacturing 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
D81375250Dry-BondDEN-MAT HOLDINGS, LLCKZP2016-09-24
D81375500Dry-BondDEN-MAT HOLDINGS, LLCKZP2016-09-24
D81380000Infinity®DEN-MAT HOLDINGS, LLCKZP2016-09-24