FDA.reportPublic FDA data

Aqua Bond Composite

Primary DI
D867CLABC0
Brand
Aqua Bond Composite
Company
Xemax Surgical Products Inc
Model
CLABC
Catalog number
CLABC
Device description
Aqua Bond Compostie is a light cure, hydrophilic bracket adhesive, which can be applied to a dry or slightly contaminated surface. The smooth cohesive past viscosity allows for easy application to any style bracket base, insuring maximum mechanical retention.
Published
2017-05-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K895522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895522000LIGHT BOND PASTE W/FLUORIDEReliance Orthodontic Products, Inc.1989-12-07DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D867CLABC0PrimaryHIBCC0

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
Special Storage Condition, Specify00Store refrigerated. (2-8 C). Protect from heat and light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0117072247817customerservice@xemax.com

Regulatory Flags#

DUNS number
804495695
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D867CLEG0Etchant GelCLEGCLEG2017-05-22
D867CLEGS0Etchant Gel SyringeCLEGSCLEGS2017-05-22
D867CLQSP0Quick Set Paste A & BCLQSPCLQSP2017-05-22
D867CLQSPA0Quick Set Paste ACLQSPACLQSPA2018-05-31
D867CLQSPB0Quick Set Paste BCLQSPBCLQSPB2018-05-31
D867RLH0Right Light RLHRLH2023-06-12
D867CLABP0Aqua Bond SealantCLABPCLABP2017-05-22
D867CSII1000C-SpongeIICSII1002022-08-08
D867CSIII1000C-SpongeIIICSIII1002022-08-08
D867CSIV1000C-SpongeIVCSIV1002022-08-08
D867CSP500C-SpongePedoCSP502022-08-08
D867CSR1000C-SpongeRegularCSR1002022-08-08
D867ELILG0Elbow ImmobilizerELILGELILG2023-06-12
D867ELISM0Elbow Immobilizer PedoELISMELISM2023-06-12
D867OSSF0Osseo II Bone TrapOSSFOSSF2023-06-12
D867CL36005Cusp-Lok 360CL360052022-09-09
D867CL36010Cusp-Lok 360CL360102022-09-09
D867CLCMLP05Cusp-Lok CMLPCLCM05LP2022-09-09
D867CLCMLP10Cusp-Lok CMLPCLCM10LP2022-09-09
D867CLCMR05Cusp-Lok CMRCLCM05R2022-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
006522210868083M™ Unitek™ Metal Brackets3M UNITEK CORPORATIONDYH2026-05-07
006522212281543M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212282223M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212282533M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212282603M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212282913M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212283073M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212283763M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212284063M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212284133M™ SmartClip™3M UNITEK CORPORATIONDYH2026-05-07
006522212998263M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998333M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998403M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998573M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998643M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998713M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998883M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522212998953M™ Victory Series™3M UNITEK CORPORATIONDYH2026-05-07
006522213074393M™ Clarity™3M UNITEK CORPORATIONDYH2026-04-25
006522213074463M™ Clarity™3M UNITEK CORPORATIONDYH2026-04-25
00190746061318No Mix30AMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061325No Mix30AMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061332No Mix30AMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061370Eagle SpectrumAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061394Eagle SpectrumAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061400Eagle No DriftAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061417Eagle SpectrumAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061431Eagle No DriftAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061455Porcelain ConditionerAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10
00190746061516MR Lock LCAMERICAN ORTHODONTICS CORPORATIONDYH2026-04-10