Rosen Implant Solutions RTB3803

GUDID 07290109745442

Ti-Base Cad/Cam Anti-Rotational 3mm

BHI IMPLANTS LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07290109745442
• NIH Device Record Key: 263f8047-aa69-498d-9d08-e5868c0933ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rosen Implant Solutions
• Version Model Number: 1
• Catalog Number: RTB3803
• Company DUNS: 600330916
• Company Name: BHI IMPLANTS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com
• Phone: +1-818-903-6736
• Email: rosen.implant.solutions@gmail.com

Device Dimensions

• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter
• Height: 3 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109745442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103280

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

[07290109745442]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-15
• Device Publish Date: 2023-02-07

On-Brand Devices [Rosen Implant Solutions]

• 07290109745466: Scan-Body For Multi Unit 13mm
• 07290109745459: Ti-Base Cad/Cam Rotational 3mm
• 07290109745442: Ti-Base Cad/Cam Anti-Rotational 3mm
• 07290109745435: Ti-Base Cad/Cam Rotational 2mm
• 07290109745428: Ti-Base Cad/Cam Anti-Rotational 2mm
• 07290109745411: Ti-Base Cad/Cam Rotational 1mm
• 07290109745404: Ti-Base Cad/Cam Anti-Rotational 1mm
• 07290109745398: Ti-Base Cad/Cam For Multi Unit & Rosen Screw
• 07290109745381: Straight Multi Unit 6mm Length
• 07290109745374: Straight Multi Unit 5mm Length
• 07290109745367: Straight Multi Unit 4mm Length
• 07290109745350: Straight Multi Unit 3mm Length
• 07290109745343: Straight Multi Unit 2mm Length
• 07290109745336: Straight Multi Unit 1mm Length
• 07290109745329: PEEK Scan-Body 9mm Length
• 07290109745312: PEEK Scan-Body 7mm Length
• 07290109745305: Straight Abutment Regular Platform Length 12mm
• 07290109745299: Straight Abutment 9 mm
• 07290109745282: Straight Abutment Regular Platform Length 7mm
• 07290109745275: Straight Abutment Regular Platform Shoulder 4mm
• 07290109745268: Straight Abutment Regular Platform Shoulder 3mm
• 07290109745251: Straight Abutment Regular Platform Shoulder 2mm
• 07290109745244: Straight Abutment Regular Platform Shoulder 1mm
• 07290109745237: Transfer For Multi Unit - Open Tray
• 07290109745220: Titanium Sleeve For Multi Unit + Rosen Screw
• 07290109745213: Scan-Body For Multi Unit 10mm
• 07290109745206: Scan-Body For Multi Unit 7mm
• 07290109745190: Healing Cap For Multi Unit
• 07290109745183: Digital Analog For Multi Unit
• 07290109745176: Digital Analog
• 07290109745169: Angled Multi Unit 45° - 3mm
• 07290109745152: Angled Multi Unit 45° - 2mm
• 07290109745145: Angled Multi Unit 45° - 1mm
• 07290109745138: Angled Multi Unit 30° - 3mm
• 07290109745121: Angled Multi Unit 30° - 2mm
• 07290109745114: Angled Multi Unit 30° - 1mm
• 07290109745107: Angled Multi Unit 17° - 3mm
• 07290109745091: Angled Multi Unit 17° - 2mm
• 07290109745084: Angled Multi Unit 17° - 1mm
• 07290109745077: Angled Abutment Regular Platform 25° - 11mm
• 07290109745060: Angled Abutment Regular Platform 25° - 9mm
• 07290109745053: Angled Abutment Regular Platform 15° - 11mm
• 07290109745046: Angled Abutment Regular Platform 15° - 9mm
• 07290109747545: Scan-Body For Multi Unit 1.72UNF 13mm
• 07290109747538: Scan-Body For Multi Unit M1.6 13mm
• 07290109747521: Scan-Body For Multi Unit 1.72UNF 10mm
• 07290109747514: Scan-Body For Multi Unit M1.6 10mm
• 07290109747507: Scan-Body For Multi Unit 1.72UNF 7mm
• 07290109747491: Scan-Body For Multi Unit M1.6 7mm