Identity
- Trade Name
- DDP Osseodensification Bur Kit FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Set of 12 burs and 4 socket guides used to prepare osteotomies for dental implant placement in the mandible and maxilla. FDA UDI
- Model / Reference
- Osseodensification Bur Kit FDA UDI
- Description
- Set of 12 burs and 4 socket guides used to prepare osteotomies for dental implant placement in the mandible and maxilla. FDA UDI
Identifiers
- Catalog Number
- Osseodensification Bur Kit FDA UDI
- Primary DI / UDI-DI
- 00083208134449 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
DDP Osseodensification Bur Kit by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI 8bcccb03-f99d-4e39-aad0-8d4ef842282c 36 fields · synced May 30, 2026