FDA.reportPublic FDA data

Celebrace

Primary DI
00860012928408
Brand
Celebrace
Company
Celebrace Inc.
Model
1
Device description
Orthodontic appliance
Published
2025-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZCWire, Orthodontic
EJFBracket, Metal, Orthodontic
QJJIndirect Bonding Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1
EJFBracket, Metal, OrthodonticDental1
QJJIndirect Bonding TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012928408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012928408008600129284088600129284080860012928408

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119479260
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

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