Identity
- Trade Name
- Carriere® SLX 3D™ FDA UDI
- Generic Name
- Self-ligating orthodontic bracket FDA UDI
- Device Name
- Carriere® SLX 3D™ Clear .022 UL1 +12T 5A 0O (RP) FDA UDI
- Model / Reference
- 776-UL1-RP FDA UDI
- Description
- Carriere® SLX 3D™ Clear .022 UL1 +12T 5A 0O (RP) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707057787 FDA UDI
- 510(k) Number
- K173440 FDA UDI
- FDA Product Code
- NJM FDA UDI
- GMDN Term
- Self-ligating orthodontic bracket FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Self-ligating orthodontic bracket
Carriere® SLX 3D™ by Ortho Organizers, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-ligating orthodontic bracket.
- VAM-22-053 — GNI Co., Ltd · Class II
- ECLIPSE PASSIVE — ORTHO ARCH COMPANY INC · Class I
- ECLIPSE PASSIVE — ORTHO ARCH COMPANY INC · Class I
- ECLIPSE INTERACTIVE — ORTHO ARCH COMPANY INC · Class I
- ECLIPSE PASSIVE — ORTHO ARCH COMPANY INC · Class I
- ADITEK — ADITEK DO BRASIL S/A
- ECLIPSE PASSIVE — ORTHO ARCH COMPANY INC · Class I
- ECLIPSE PASSIVE — ORTHO ARCH COMPANY INC · Class I
Cleared under the same submission
K173440 also covers:
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
- Carriere® SLX 3D™ — Ortho Organizers, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho Organizers, Inc.
Sources (1)
- FDA UDI 9cab1345-7cb5-4eb4-9864-384e259640f6 34 fields · synced Jun 9, 2026