Bone Molder - Offset Bone Molder - Offset

GUDID 00083208130137

Bone molder - used to compress bone in between dental Implants at time of placement - Offset to allow access to posterior

Suncoast Dental, Inc

Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument Osteotomy compression/distraction instrument

• Primary Device ID: 00083208130137
• NIH Device Record Key: 66932313-3e33-4c8b-91b3-b372db651e3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Molder - Offset
• Version Model Number: Bone Molder - Offset
• Catalog Number: Bone Molder - Offset
• Company DUNS: 078352849
• Company Name: Suncoast Dental, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com
• Phone: 727-536-4880
• Email: tatumcompliance@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208130137 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

[00083208130137]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-11
• Device Publish Date: 2021-02-03

Devices Manufactured by Suncoast Dental, Inc

• 00083208135002 - DDP Dental Mirror: 2024-02-07 Dental Mirror, reusable
• 00083208136702 - DDP Extraction Forceps: 2024-02-07 Tooth Extraction Forceps 67A
• 00083208452215 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 2.0mm Cuff Height
• 00083208453212 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 3.0mm Cuff Height
• 00083208454219 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 4.0mm Cuff Height
• 00083208455216 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 5.0mm Cuff Height
• 00083208456213 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 4.5mm Diameter "P" Implants 6.0mm Cuff Height
• 00083208502217 - Tatum Surgical IP Press Fit Abutment: 2023-01-13 0° (Degree) Shouldered Abutment for 5.0mm Diameter "P" Implants 2.0mm Cuff Height