Tatum Surgical-Osteotome Kit
Tatum Universal Straight Osteotome Kit designed for use in bone expansion: Includes 24 instruments and 2 Autoclaveable cassettes: Bone Scalpels (Blue) - BS4.0, 5.0 & 6.0, Bone Blades…
Tatum Universal Straight Osteotome Kit designed for use in bone expansion: Includes 24 instruments and 2 Autoclaveable cassettes: Bone Scalpels (Blue) – BS4.0, 5.0 & 6.0, Bone Blades (Green) – BB5.5, 7.5, & 10.0, “D” Shape (Black) – D1-4.0, D2-5.5, D3-7.5, & D4-10.0, Round Tapered (White) – RT2.0, 3.0, 4.0, & 5.0 Round Parallel Pointed (Yellow) – RP3.0, 3.5, 4.0, 4.5, & 5.0, Round Parallel Blunt (Red) – RB3.0, 3.5, 4.0, 4.5, & 5.0
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Suncoast Dental, Inc., United States |
|---|---|
| FDA product code | EMM |
| Device type | Chisel, Osteotome, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Tatum Universal Straight Osteotome Kit | In distribution | |
| Tatum Universal Offset Osteotome Kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 482 |
| gSource | Gsource, LLC. | 296 |
| Tatum Surgical-Osteotome | Suncoast Dental, Inc. | 108 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 101 |
| Kohdent | Kohler Medizintechnik GmbH | 86 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 78 |
| ACE | Ace Surgical Supply Co., Inc. | 73 |
| Osteotome | KLS-Martin L.P. | 70 |
| Aesculap | Aesculap AG | 69 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 64 |
| Millennium | Avalign Technologies, Inc. | 63 |
| devemed | Devemed Gmbh | 63 |
Showing 12 of 283. All products under Chisel, Osteotome, Surgical
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.