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
00840456205389JMUJMU DENTAL, INCEJF2026-06-25
00840456205396JMUJMU DENTAL, INCEJF2026-06-25
00840456205402JMUJMU DENTAL, INCEJF2026-06-25
00840456205419JMUJMU DENTAL, INCEJF2026-06-25
00840456209363JMUJMU DENTAL, INCDZC2026-06-24
00840456209370JMUJMU DENTAL, INCDZC2026-06-24
00840456209387JMUJMU DENTAL, INCDZC2026-06-24
00840456209394JMUJMU DENTAL, INCDZC2026-06-24
00840456209400JMUJMU DENTAL, INCDZC2026-06-24
00840456209417JMUJMU DENTAL, INCDZC2026-06-24
00840456209424JMUJMU DENTAL, INCDZC2026-06-24
00840456209431JMUJMU DENTAL, INCDZC2026-06-24
00840456209448JMUJMU DENTAL, INCDZC2026-06-24
00840456209455JMUJMU DENTAL, INCDZC2026-06-24
00840456209462JMUJMU DENTAL, INCDZC2026-06-24
00840456209479JMUJMU DENTAL, INCDZC2026-06-24
00840456209486JMUJMU DENTAL, INCDZC2026-06-24
00840456209493JMUJMU DENTAL, INCDZC2026-06-24
00840456209509JMUJMU DENTAL, INCDZC2026-06-24
00840456209516JMUJMU DENTAL, INCDZC2026-06-24
00840456209523JMUJMU DENTAL, INCDZC2026-06-24
00840456209530JMUJMU DENTAL, INCDZC2026-06-24
00840456209547JMUJMU DENTAL, INCDZC2026-06-24
00840456209554JMUJMU DENTAL, INCDZC2026-06-24
00840456209561JMUJMU DENTAL, INCDZC2026-06-24
00840456209578JMUJMU DENTAL, INCDZC2026-06-24
00840456209585JMUJMU DENTAL, INCDZC2026-06-24
00840456209592JMUJMU DENTAL, INCDZC2026-06-24
00840456209608JMUJMU DENTAL, INCDZC2026-06-24
00840456209615JMUJMU DENTAL, INCDZC2026-06-24