Identity
- Trade Name
- 3M™ FDA UDI
- Generic Name
- Orthodontic appliance positioning tray FDA UDI
- Device Name
- 3M™ Digital Bonding Tray FDA UDI
- Model / Reference
- EXD-982 FDA UDI
- Description
- 3M™ Digital Bonding Tray FDA UDI
Identifiers
- Catalog Number
- EXD-982 FDA UDI
- Primary DI / UDI-DI
- 00605861074759 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Orthodontic appliance positioning tray FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic appliance positioning tray
3m™ by 3m Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic appliance positioning tray.
- FotoDent® IBT 385 nm — Dreve Dentamid GmbH · Class I
- Celebrace — Celebrace · Class I
- SureSmile® — ORAMETRIX, INC. · Class I
- Digital Orthodontic Care — Digital Orthodontic Care · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA UDI 6674f675-8a8a-4d00-9f7e-5f86f199c637 35 fields · synced May 30, 2026