Manufacturer registered with FDA

Celebrace

Colleyville, TX, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10091420Manufacturer1 clearance in five years
Device types listed
4
Brands and models
4
510(k) clearances
12025–2025
Markets registered in
1United States
Establishments
1United States
2025: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Celebrace currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic WireDZC · Class 1Orthodontic wires & bandsMaker
Celebrace AI Wire
2024
Orthodontic Metal BracketEJF · Class 1Orthodontic bracketsMaker
Celebrace Custom Brackets
2024
Orthodontic SoftwarePNN · Class 2Dental design & orthodontic softwareMaker
Celebrace Software
2026
Indirect Bonding TrayQJJ · Class 1—Maker
Celebrace Bonding Tray
2024

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Celebrace as the applicant.

Decided510(k)DeviceDevice type
29 Dec 2025K253343Celebrace SoftwarePNN Orthodontic Software

Registered establishments

EstablishmentLocationWhat it does
CelebraceFDA reg. 3033714666Colleyville, TX, United StatesComplaint file establishment, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10091420). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.