FDA.report

Resilience

Primary DI
00190730006592
Brand
Resilience
Company
ORTHO TECHNOLOGY, INC.
Model
FC-RESI-008
Device description
LV Flowable Composite Syringe 2gms. + 10 syringe tips
Published
2017-05-12
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
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190730006592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190730006592001907300065921907300065920190730006592

GMDN Terms

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

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
true
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

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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
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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
00840479203652EXCEL REGULARRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-13
07290115050035High-Q-Bond Bracket AdhesiveB.J.M. LABORATORIES LTDDYH2026-03-13
07290115051896Ideal 1 Orthodontic Bracket AdhesiveB.J.M. LABORATORIES LTDDYH2026-03-13
07290115051902High-Q-Bond BandB.J.M. LABORATORIES LTDDYH2026-03-13
00840479203317RELY A BONDRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-12
00840479202372PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202389PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202396PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202402PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202419PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202426PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202433PLASTIC CONDITIONERRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202440PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202457PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202464PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479202570PHASE IIRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-11
00840479201894LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201900LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201924LIGHT BOND THIN PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201931LIGHT BOND FILLED SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201948LIGHT BOND FILLED SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201979LIGHT BOND REGULAR SEALANTRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201986LIGHT BOND MEDIUM PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479201993LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202006LIGHT BOND REGULAR PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202082MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202099MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202105MAXIMUM CURERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202136METAL PRIMERRELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10
00840479202259PADLOCK PASTERELIANCE ORTHODONTIC PRODUCTS INCDYH2026-03-10