Identity
- Trade Name
- ESI FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- ESI Implant - Internal Hex 4.3mmx10mm RBM Surface FDA UDI
- Model / Reference
- ESI43010R FDA UDI
- Description
- ESI Implant - Internal Hex 4.3mmx10mm RBM Surface FDA UDI
Identifiers
- Catalog Number
- ESI43010R FDA UDI
- Primary DI / UDI-DI
- D890ESI43010R0 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Screw endosteal dental implant, two-piece
Esi by Spiraltech Superior Dental Implants, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Spiraltech Superior Dental Implants, Inc.
Sources (1)
- FDA UDI 66ecda49-7610-4fef-95f6-2c2618f4179b 35 fields · synced Jun 1, 2026