Identity
- Trade Name
- SURGYSTAR FDA UDI
- Generic Name
- Dental ultrasonic surgical system FDA UDI
- Model / Reference
- G01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809462190005 FDA UDI
- 510(k) Number
- K113152 FDA UDI
- FDA Product Code
- DZI FDA UDI
- GMDN Term
- Dental ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental ultrasonic surgical system
Surgystar by Dmetec.Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental ultrasonic surgical system.
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- TS Tip — B&L Biotech Co., Ltd. · Class I
- JETIP Bendable Jig — B&L Biotech Co., Ltd. · Class I
- TS Tip — B&L Biotech Co., Ltd. · Class I
- BONE TIP HOLDER SET (8 TIPS) — BONART CO., LTD. · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
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
- Dmetec.Co., Ltd.
Sources (1)
- FDA UDI 418bc839-f66a-404a-aed0-06845bfeeb2e 34 fields · synced May 30, 2026