FDA.report

Relastics

Primary DI
00840479202808
Brand
Relastics
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
EL56X
Published
2025-09-17
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
ECIBand, Elastic, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840479202808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479202808008404792028088404792028080840479202808

GMDN Terms

TermDefinition
Orthodontic inter-arch elastic bandA non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Sterilization Methods

Method

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
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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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

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Primary DIBrandCompanyProduct codePublished
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