FDA.reportPublic FDA data

Ortho FlexTech

Primary DI
D798OFT20
Brand
Ortho FlexTech
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
OFT2
Catalog number
OFT2
Device description
Intended for use as a Lingual Retainer Wire. Ortho Flex Tech® is best used for lower lingual 3 to 3 retainers and upper lingual 2 to 2 fixed retainers. This is 14karat White Gold
Published
2016-08-06
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
true

Product Codes#

Code, Name table
CodeName
DZCWire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798OFT20PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient conditions.

Contacts#

Phone, Email table
PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags#

DUNS number
113170088
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D798EMHAPR0EtchmasterEMHAPR2021-07-13
D798ASK0ASKASKASK2016-07-25
D798ASKU0ASKASKUASKU2016-07-25
D798EMCO20EtchmasterEMCO2EMCO22016-09-09
D798EMGAS0EtchmasterEMGASEMGAS2016-09-03
D798EMHA0EtchmasterEMHAEMHA2016-09-03
D798EMHAR0EtchmasterEMHAREMHAR2016-09-04
D798EMTLL1EtchmasterEMTLLEMTLL2016-09-04
D798EMTLS1EtchmasterEMTLSEMTLS2016-09-04
D798EMTRL1EtchmasterEMTRLEMTRL2016-09-04
D798EMTRS1EtchmasterEMTRSEMTRS2016-09-04
D798USEP0Ultra SEPUSEP2022-03-03
D798PPA10Perfect A SmilePPA1PPA12019-09-10
D798PPD30Perfect A SmilePPD3PPD32019-09-10
D798EL240EtchantEL24EL242016-08-10
D798EL24C0EtchantEL24CEL24C2016-08-10
D798LBMPPF0LIGHT BONDLBMPPFLBMPPF2016-08-03
D798LBPP0Light BondLBPPLBPP2016-08-03
D798LBS30Light BondLBS3LBS32016-08-03
D798LBS3F0Light BondLBS3FLBS3F2016-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190746202841Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202858Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202865Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202872Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202889Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202896Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202902Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202919Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202926Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202933Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202940Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202957Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202964Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202971Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202988Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202995Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203008Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203015Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203022Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203039Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203046Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203053Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203060Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203077Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203084Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203091Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203107Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203114Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203121Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203138Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29