Identity
- Trade Name
- BASIS HI FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Model / Reference
- 10KG,LF PINK FDA UDI
Identifiers
- Primary DI / UDI-DI
- D080XXBHI10KGXXLFP0 FDA UDI
- 510(k) Number
- K131036 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, resin
Basis Hi by Yamahachi Dental Mfg., Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131036 also covers:
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- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yamahachi Dental Mfg., Co.
Sources (1)
- FDA UDI 087dd617-c597-49f6-98c7-4235983f8d9e 33 fields · synced Jun 8, 2026