FDA.report

Resilience

Primary DI
00190730000149
Brand
Resilience
Company
ORTHO TECHNOLOGY, INC.
Model
506107
Device description
Liquid Etchant Large Bottle 29.6mL (1 fl oz) per bottle
Published
2016-09-24
Public version status
Update
Distribution status
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
00190730000149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190730000149001907300001491907300001490190730000149

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
781772017
Device count
1
DM exempt
true
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
10190730084535Clear Advantage7500-1002025-07-24
10190730084542Clear Advantage7500-1052025-07-24
10190730084559Clear Advantage7500-1102025-07-24
10190730084566Clear Advantage7500-0352025-07-24
10190730084573Clear Advantage7500-0402025-07-24
10190730084580Sports Advantage7500-1652025-07-24
10190730084597Sports Advantage7500-1402025-07-24
00190730084682Ortho TechnologyOT-000-SS2024-09-18
00190730084811Ortho TechnologyOT-000-SS-D2024-09-18
00190730084828Ortho TechnologyOT-2118-SS2024-09-18
00190730084835Ortho TechnologyOT-2118-SSD2024-09-18
00190730084842Ortho TechnologyOT-2122-SS2024-09-18
00190730084859Ortho TechnologyOT-2122-SSD2024-09-18
00190730084354Ortho TechnologyOT-0272024-09-17
00190730084361Ortho TechnologyOT-0282024-09-17
00190730084378Ortho TechnologyOT-2032024-09-17
00190730084385Ortho TechnologyOT-2042024-09-17
00190730084392Ortho TechnologyOT-2062024-09-17
00190730084439Ortho TechnologyOT-2092024-09-17
00190730084507Ortho TechnologyOT-209R2024-09-17

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