Identity
- Trade Name
- DS Tip FDA UDI
- Generic Name
- Dental ultrasonic surgical system FDA UDI
- Model / Reference
- DS-XRE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019151661 FDA UDI
- FDA Product Code
- JET FDA UDI
- GMDN Term
- Dental ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental ultrasonic surgical system
DS Tip by B&L Biotech Co., Ltd. — Class I — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental ultrasonic surgical system.
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- ACTEON — Satelec · Class II
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- BONE TIP/BM-EL3 — BONART CO., LTD. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- B&L Biotech Co., Ltd.
Sources (2)
- FDA UDI 223d1a22-f38d-41c2-ba0d-e1490bca4410 32 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 29, 2026