FDA.report

ETCH ROYALE™ DENTAL ETCHING GEL

Primary DI
D701ER12G2
Brand
ETCH ROYALE™ DENTAL ETCHING GEL
Company
PULPDENT CORPORATION
Model
ER12G
Device description
12 gm (8.7 mL) syringe 37% Phosphoric Acid
Published
2016-08-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D701ER12G2PrimaryHIBCC0

GMDN Terms

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.

Device Sizes

TypeValueUnit
Weight12Gram

Sterilization Methods

Method

Regulatory Flags

DUNS number
001006089
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 DIBrandModelCatalogPublished
D701VBF2US2ACTIVA™ BioACTIVE Bulk FlowVBF2US2025-05-12
D701VKBFS2ACTIVA™ Kids BioACTIVE Bulk FlowVKBFS2025-05-12
D701T20G191Applicator TipsT20G192024-12-03
D701SVBFUS2ACTIVA™ BioACTIVE Bulk FlowS-VBFUS2024-12-02
D701SVKBFUS2ACTIVA™ Kids BioACTIVE Bulk FlowS-VKBFUS2024-12-02
D701VBF1US2ACTIVA™ BioACTIVE Bulk FlowVBF1US2024-12-02
D701VKBF1OW2ACTIVA™ Kids BioACTIVE Bulk FlowVKBF1OW2024-12-02
D710VKBF1US2ACTIVA™ Kids BioACTIVE Bulk FlowVKBF1US2024-12-02
D701SUNO2DENTASTIC UNO SAMPLESUNO2018-08-10
D701SVPFA32Activa PrestoS-VPFA32023-06-22
D701SVPFA352Activa PrestoS-VPFA352023-06-22
D701SVPFA42Activa PrestoS-VPFA42023-06-22
D701SVPFA62Activa PrestoS-VPFA62023-06-22
D701SVPFB12Activa PrestoS-VPFB12023-06-22
D701TTP502Tuff Temp Plus Provisional Veneer, Crown, and Bridge ResinTTP502018-12-14
D701TTP50A12TUFF-TEMP PLUSTTP50A12019-11-22
D701TTP50A1X2TUFF-TEMP PLUSTTP50A1X2019-11-22
D701TTP50A22TUFF-TEMP PLUSTTP50A22019-11-22
D701TTP50A2X2TUFF-TEMP PLUSTTP50A2X2019-11-22
D701TTP50A32TUFF-TEMP PLUSTTP50A32019-11-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815967022503PacBondPac-Dent, Inc.KLE2026-03-24
00815967023005PacBondPac-Dent, Inc.KLE2026-03-24
00815967027454RodinPac-Dent, Inc.KLE2026-03-24
00815967027461RodinPac-Dent, Inc.KLE2026-03-24
00815967027478RodinPac-Dent, Inc.KLE2026-03-24
00815967027485RodinPac-Dent, Inc.KLE2026-03-24
00815967022404PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022411PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022589PacEtchPac-Dent, Inc.KLE2026-03-23
00815967029984RodinPac-Dent, Inc.KLE2026-03-23
DVIV687778WW0Adhese Universal DCIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-03-17
DVIV687779WW0Adhese Universal DCIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-03-17
07290115050196Prima Quick PrimeB.J.M. LABORATORIES LTDKLE2026-03-13
07290115051889Smile Stream STEP-1 PumEtchB.J.M. LABORATORIES LTDKLE2026-03-13
00840479203409SELF ETCHING PRIMER REFILL CARTRIDGERELIANCE ORTHODONTIC PRODUCTS INCKLE2026-03-12
00840479203546ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-03-12
00840481135286MICROPRIMEZest Anchors, LLCKLE2026-03-10
00840481135293MICROPRIMEZest Anchors, LLCKLE2026-03-10
00840479200767ASSURE UNIVERSAL BONDING RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200859BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200897ASSURE UNIVERSAL BONDING RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200781ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200798ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200804ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479203591ULTRA SELF ETCHING PRIMERRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479203607ULTRA SELF ETCHING PRIMERRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200071BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-18
00840479200088BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-18
00190746071003Acid EtchantAMERICAN ORTHODONTICS CORPORATIONKLE2026-01-28
00850079280120HexaHexa DentalKLE2026-01-21