FDA.report

Colored Chain

Primary DI
00190746058752
Brand
Colored Chain
Company
AMERICAN ORTHODONTICS CORPORATION
Model
854-298
Catalog number
854-298
Device description
CHAIN PLASTIC 15' CLOSED SILVER
Published
2022-07-22
Public version status
New
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

Contact Domains

Product Codes

CodeName
ECIBAND, ELASTIC, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190746058752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746058752001907460587521907460587520190746058752

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).

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Light
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius38 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags

DUNS number
044668515
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
false
No natural rubber latex
true
Sterilization required before use
false

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00190746067549PowerScope852-016539852-0165392026-03-24
00190746067563PowerScope852-016540852-0165402026-03-24
00190746067587PowerScope852-030576852-0305762026-03-24
00190746153273PowerScope852-016541852-0165412026-03-24
00190746202742PowerScope852-016538852-0165382026-03-24
00190746202759PowerScope852-016537852-0165372026-03-24
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00190746191619Empower Bracket475-128VSCC475-128VSCC2026-03-23
00190746191626Empower Bracket475-2112VSCC475-2112VSCC2026-03-23
00190746191633Empower Bracket475-228VSCC475-228VSCC2026-03-23
00190746191640Empower Bracket475-310VSCC475-310VSCC2026-03-23
00190746191657Empower Bracket475-410VSCC475-410VSCC2026-03-23
00190746191664Empower Bracket585-130BVSCC585-130BVSCC2026-03-23
00190746191671Empower Bracket585-140BVSCC585-140BVSCC2026-03-23
00190746191688Empower Bracket585-140VSCC585-140VSCC2026-03-23
00190746191695Empower Bracket585-230BVSCC585-230BVSCC2026-03-23
00190746191701Empower Bracket585-240BVSCC585-240BVSCC2026-03-23
00190746191718Empower Bracket585-240VSCC585-240VSCC2026-03-23
00190746191725Empower Bracket585-330BVSCC585-330BVSCC2026-03-23
00190746191732Empower Bracket585-340BVSCC585-340BVSCC2026-03-23

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