Identity
- Trade Name
- OrthoFlex FDA UDI
- Generic Name
- Orthodontic bracket, plastic, single-use FDA UDI
- Device Name
- OrthoFlex Std Edge U/L R/L 4/5 .018 SLOT(10PK) FDA UDI
- Model / Reference
- COM-403 FDA UDI
- Description
- OrthoFlex Std Edge U/L R/L 4/5 .018 SLOT(10PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190730001740 FDA UDI
- 510(k) Number
- K973776 FDA UDI
- FDA Product Code
- DYW FDA UDI
- GMDN Term
- Orthodontic bracket, plastic, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
OrthoFlex by Ortho Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K973776 also covers:
- COMPOSITE EYELETS — G&H Wire Company, Inc.
- LUCENT™ EDGEWISE METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- LUCENT™ MBT METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- LUCENT™ MBT METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- LUCENT™ ROTH METAL LINED COMPOSITE BRACKETS — G&H Wire Company, Inc.
- PRISM™ EDGEWISE COMPOSITE BRACKET (KIT) — G&H Wire Company, Inc.
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc.
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc.
- PRISM™ MBT COMPOSITE BRACKETS — G&H Wire Company, Inc.
- PRISM™ ROTH COMPOSITE BRACKET — G&H Wire Company, Inc.
- PRISM™ ROTH COMPOSITE BRACKET — G&H Wire Company, 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 |
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Manufacturer
- Manufacturer
- Ortho Technology, Inc.
Sources (1)
- FDA UDI dd3d00f5-f13c-4017-9eb4-00b8a73f3676 35 fields · synced May 31, 2026