FDA.report

Retainium

Primary DI
D798RETSAM0
Brand
Retainium
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
RETSAM
Catalog number
RETSAM
Device description
Retainium is intended for use as a lingual retention wire. This is a single strand for sample evaluation.
Published
2016-10-18
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
true

Related Records

Product Codes

CodeName
DZCWire, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798RETSAM0PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic retainerA dental orthodontic appliance, fixed or removable, used to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient conditions.

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
Device count
1
DM exempt
true
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
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
00840479203621RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-13
00840479203249RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203256RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203263RETAINIUM LINGUAL RETENTION WIRERELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203294RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203300RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203379BOND A BRAID 6 INCH LINGUAL RETAINER WIRESRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203461ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-12
00840479203133RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203140RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203157RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203164RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203171RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203188RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203195RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203201RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479203218RELIAMOLDSRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-11
00840479202198ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202204ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202235ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479202242ORTHO FLEXTECHRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-10
00840479201146DISPOSABLE C&C OVAL APPLICATOR WITHOUT CHAIN (1)RELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-04
00840479201153DISPOSABLE C&C PAD ATTACHMENT WITH CHAIN (1)RELIANCE ORTHODONTIC PRODUCTS INCDZC2026-03-04
00840479200828BOND A BRAID 6 INCH LINGUAL RETAINER WIRESRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-23
00840479200415RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200422RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200439RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200446RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200453RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20
00840479200460RELIAMOLDRELIANCE ORTHODONTIC PRODUCTS INCDZC2026-02-20