FDA.reportPublic FDA data

Etchant Gel

Primary DI
D867CLEG0
Brand
Etchant Gel
Company
Xemax Surgical Products Inc
Model
CLEG
Catalog number
CLEG
Device description
Etchant Gel is 37% phosphoric acid (H3PO4) polymer-thickened and intended for use on enamel to prepare the surface for bonding. 9g etch in bottle.
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
KLEAGENT, TOOTH BONDING, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K875313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875313000PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYSTBisco, Inc.1988-03-10EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D867CLEG0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature (15-30 Degrees C )

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
D867CLEGS0Etchant Gel SyringeCLEGSCLEGS2017-05-22
D867CLABC0Aqua Bond CompositeCLABCCLABC2017-05-22
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
00850194007763Zr-P BottleVista DentalKLE2026-06-04
08809518342105Hi-Bond UniversalMEDICLUS CO.,LTDKLE2026-06-01
00197998024269Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024276Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
D0019064140LucitoneDentsply International Inc.KLE2025-07-01
D0019064150LucitoneDentsply International Inc.KLE2025-07-01
D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
07615208298536Monobond PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2024-01-24
D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14
07615208293128Adhese 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208295375Monobond Etch & PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296136Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296143Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297362ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297379ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06