FDA.report

GEL ETCHANT

Primary DI
00840479201160
Brand
GEL ETCHANT
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
EGSS
Published
2026-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798EGSS0PreviousHIBCC0
00840479201160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479201160008404792011608404792011600840479201160

GMDN Terms

TermDefinition
Dental tooth-etching solutionAn acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
113170088
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
00840479201481RENEW SYSTEM POINTSFGSAM22026-03-13
00840479203614ULTRA VIOLET MINI LIGHTUVML2026-03-13
00840479203621RETAINIUM LINGUAL RETENTION WIREXLRETSAM2026-03-13
00840479203652EXCEL REGULARERJAF2026-03-13
00840479203669SYRINGE WING (1)WING2026-03-13
00840479203249RETAINIUM LINGUAL RETENTION WIRERET2026-03-12
00840479203256RETAINIUM LINGUAL RETENTION WIREXLRET2026-03-12
00840479203263RETAINIUM LINGUAL RETENTION WIRERETSAM2026-03-12
00840479203270MIXING RESERVOIR RING WELRW2026-03-12
00840479203287MIXING RESERVOIR RING WELRWSAM2026-03-12
00840479203294RELIAMOLDSRMK2026-03-12
00840479203300RELIAMOLDSRMKB2026-03-12
00840479203317RELY A BONDRPF2026-03-12
00840479203324RELIAWAXRWX2026-03-12
00840479203331RELIAWAXRWXSAM2026-03-12
00840479203348SPATULAS2026-03-12
00840479203355SAFETY GLASSESSG2026-03-12
00840479203362SAFETY GLASSESSGU2026-03-12
00840479203379BOND A BRAID 6 INCH LINGUAL RETAINER WIRESSAMBAB22026-03-12
00840479203409SELF ETCHING PRIMER REFILL CARTRIDGESEPR2026-03-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815967025856RodinPac-Dent, Inc.EBF2026-03-24
00815967025863RodinPac-Dent, Inc.EBF2026-03-24
00815967025870RodinPac-Dent, Inc.EBF2026-03-24
00815967021438OptiCompPac-Dent, Inc.EBF2026-03-23
00815967021797OptiCompPac-Dent, Inc.EBF2026-03-23
00815967027447RodinPac-Dent, Inc.EBF2026-03-23
00815967028161RodinPac-Dent, Inc.EBF2026-03-23
00815967028178RodinPac-Dent, Inc.EBF2026-03-23
00815967028185RodinPac-Dent, Inc.EBF2026-03-23
00815967028192RodinPac-Dent, Inc.EBF2026-03-23
00815967028208RodinPac-Dent, Inc.EBF2026-03-23
00815967028215RodinPac-Dent, Inc.EBF2026-03-23
00815967028222RodinPac-Dent, Inc.EBF2026-03-23
00815967028239RodinPac-Dent, Inc.EBF2026-03-23
00815967028246RodinPac-Dent, Inc.EBF2026-03-23
00815967028253RodinPac-Dent, Inc.EBF2026-03-23
00815967028260RodinPac-Dent, Inc.EBF2026-03-23
00815967028277RodinPac-Dent, Inc.EBF2026-03-23
00815967028284RodinPac-Dent, Inc.EBF2026-03-23
00815967028291RodinPac-Dent, Inc.EBF2026-03-23
00815967028307RodinPac-Dent, Inc.EBF2026-03-23
00815967028314RodinPac-Dent, Inc.EBF2026-03-23
00815967028321RodinPac-Dent, Inc.EBF2026-03-23
00815967028338RodinPac-Dent, Inc.EBF2026-03-23
00815967028345RodinPac-Dent, Inc.EBF2026-03-23
00815967028352RodinPac-Dent, Inc.EBF2026-03-23
00815967028369RodinPac-Dent, Inc.EBF2026-03-23
00815967028376RodinPac-Dent, Inc.EBF2026-03-23
00815967028383RodinPac-Dent, Inc.EBF2026-03-23
00815967028390RodinPac-Dent, Inc.EBF2026-03-23