Identity
- Trade Name
- Tatum One Piece Implant Kit Master FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Tatum One Piece Implant Kit Master: A kit designed for simplicity and ease of use in placing Tatum One Piece Implants 3.0-8.0: Kit Includes: DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.0x14, DR3.5x14, DR4.0x14, DR4.5x14, DR5.0x14, DR6.0x14, DR7.0x14, & DR8.0x14. HT.02, 12, 13, 14, 15, 16, 17, 18, 20, 21, 22, 23, 24, 25, 31 & 32. Tatum Ratchet. Autoclaveable Cassette/Container for all pieces. FDA UDI
- Model / Reference
- Master One Piece Implant Kit 3.0-8.0 FDA UDI
- Description
- Tatum One Piece Implant Kit Master: A kit designed for simplicity and ease of use in placing Tatum One Piece Implants 3.0-8.0: Kit Includes: DR1.5 Pilot drill, DR2.0 Pilot drill, DR3.0x14, DR3.5x14, DR4.0x14, DR4.5x14, DR5.0x14, DR6.0x14, DR7.0x14, & DR8.0x14. HT.02, 12, 13, 14, 15, 16, 17, 18, 20, 21, 22, 23, 24, 25, 31 & 32. Tatum Ratchet. Autoclaveable Cassette/Container for all pieces. FDA UDI
Identifiers
- Catalog Number
- ASY One-Piece Kit Advd FDA UDI
- Primary DI / UDI-DI
- 00083208122224 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
Category: Dental implant system
Tatum One Piece Implant Kit Master by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
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- Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI dc869793-5701-4e34-adff-981178fb19a7 35 fields · synced May 31, 2026