Identity
- Trade Name
- Bands, "T" Type FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- T-Bands EUDAMEDStainless-.002/.05mm Thick (Box of 100). Straight – Wide (1/4”) FDA UDI
- Model / Reference
- BTSS/W EUDAMEDBTSSW FDA UDI
- Description
- Stainless-.002/.05mm Thick (Box of 100). Straight – Wide (1/4”) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701BTSSW2 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D701BT9U EUDAMED
- Unit of Use DI
- D701BTSSW1 EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
T-Bands by Pulpdent Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D701BT9U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- EUDAMED SRN
- US-MF-000004897
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 3efc0fdb-fb37-4ab9-81d0-6e1d12e50940 61 fields · synced Jun 18, 2026
- FDA UDI 26790a81-6d2a-46b1-892e-d6ae6d0cddf3 33 fields · synced May 30, 2026