Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Bone cutter FDA UDI
- Device Name
- V-LC1 surgery tip compatible Satelec HYGITECH Reference: HY-98122 Flat cutting chisel for extraction. Surgery tip mainly used in root osteoplasty. It allows to penetrate deeply and with caution along the alveolar ligament (desmodontium), between the bone and the alveolar root Length: 9 mm Compatible with : Piezotome Solo (LED), Piezotome 2, Implant Center™ 2 FDA UDI
- Model / Reference
- HY-98122 FDA UDI
- Description
- V-LC1 surgery tip compatible Satelec HYGITECH Reference: HY-98122 Flat cutting chisel for extraction. Surgery tip mainly used in root osteoplasty. It allows to penetrate deeply and with caution along the alveolar ligament (desmodontium), between the bone and the alveolar root Length: 9 mm Compatible with : Piezotome Solo (LED), Piezotome 2, Implant Center™ 2 FDA UDI
Identifiers
- Catalog Number
- HY-98122 FDA UDI
- Primary DI / UDI-DI
- 03615140005500 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Bone cutter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone cutter
Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Hygitech
Sources (1)
- FDA UDI 7bfbb4b5-5984-47f6-92f6-ca1e6e5f40f6 34 fields · synced Jun 8, 2026