Dental Solution D-SP5013

GUDID 07290109745756

Spiral Implant - Ø5.0 X Length 13.0mm Wide Body 2.42 Internal Hex

BHI IMPLANTS LTD

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• Primary Device ID: 07290109745756
• NIH Device Record Key: 0d45710b-07e2-49cb-9216-6980e26209cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Solution
• Version Model Number: 1
• Catalog Number: D-SP5013
• 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: true
• 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: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com
• Phone: +972046094458
• Email: info@bh-implants.com

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 13 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	07290109745756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103280

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-05
• Device Publish Date: 2023-09-27

On-Brand Devices [Dental Solution]

• 07290109747378: Ti-Base Digital Cad/Cam For Multi Unit + Scerw
• 07290109747361: PEEK Scan-Body CAD/CAD + Screw For Multi Unit Regular 2.42 Internal Hex
• 07290109747354: Digital Cad/Cam Analog For Multi Unit
• 07290109747347: PEEK Scan-Body For Implant 9mm Length
• 07290109747330: PEEK Scan-Body For Implant 7mm Length
• 07290109747323: Ti-Base Sirona Cad/Cam For Implant Without Hex 0.5mm Regular 2.42 Internal Hex
• 07290109747316: Ti-Base Sirona Cad/Cam For Implant With Hex 0.5mm Regular 2.42 Internal Hex
• 07290109747309: Digital Analog For Implant
• 07290109747293: Ti-Base Cad/Cam For Implant Without Hex 2.5mm Regular 2.42 Internal Hex
• 07290109747286: Ti-Base Cad/Cam For Implant Without Hex 1.5mm Regular 2.42 Internal Hex
• 07290109747279: Ti-Base Cad/Cam For Implant Without Hex 0.5mm Regular 2.42 Internal Hex
• 07290109747262: Ti-Base Cad/Cam For Implant With Hex 2.5mm Regular 2.42 Internal Hex
• 07290109747255: Ti-Base Cad/Cam For Implant With Hex 1.5mm Regular 2.42 Internal Hex
• 07290109747248: Ti-Base Cad/Cam For Implant With Hex 0.5mm Regular 2.42 Internal Hex
• 07290109747231: Angled Multi Unit 30° - 3mm + Holder Mount + Screw Regular 2.42 Internal Hex
• 07290109747224: Angled Multi Unit 30° - 2mm + Holder Mount + Screw Regular 2.42 Internal Hex
• 07290109747217: Angled Multi Unit 30° - 1mm + Holder Mount + Screw Regular 2.42 Internal Hex
• 07290109747200: Angled Multi Unit 18° - 3mm + Holder Mount + Screw Regular 2.42 Internal Hex
• 07290109747194: Angled Multi Unit 18° - 2mm + Holder Mount + Screw Regular 2.42 Internal Hex
• 07290109747187: Angled Multi Unit 18° - 1mm + Holder Mount + Screw Regular 2.42 Internal Hex
• 07290109747149: Ball Adapter For Multi Unit
• 07290109747132: Healing Cap For Multi Unit
• 07290109747125: Analog For Multi Unit
• 07290109747118: Fixation Screw For MU Sleeve
• 07290109747101: Transfer For Multi Unit + Long Screw (Open Tray)
• 07290109747095: Transfer For Multi Unit + Short Screw (Close Tray)
• 07290109747088: Titanium Sleeve For MU + Screw
• 07290109747071: Plastic Sleeve For MU + Screw
• 07290109747064: Straight Multi Unit 6mm Legnth Regular 2.42 Internal Hex
• 07290109747057: Straight Multi Unit 5mm Legnth Regular 2.42 Internal Hex
• 07290109747040: Straight Multi Unit 4mm Legnth Regular 2.42 Internal Hex
• 07290109747033: Straight Multi Unit 3mm Legnth Regular 2.42 Internal Hex
• 07290109747026: Straight Multi Unit 2mm Legnth Regular 2.42 Internal Hex
• 07290109747019: Straight Multi Unit 1mm Legnth Regular 2.42 Internal Hex
• 07290109747002: Locator Angled 30°-3mm Length Regular 2.42 Internal Hex
• 07290109746999: Locator Angled 30°-2mm Length Regular 2.42 Internal Hex
• 07290109746982: Locator Angled 30°-1mm Length Regular 2.42 Internal Hex
• 07290109746975: Locator Angled 30°-0.5mm Length Regular 2.42 Internal Hex
• 07290109746968: Locator Angled 18°-3mm Length Regular 2.42 Internal Hex
• 07290109746951: Locator Angled 18°-2mm Length Regular 2.42 Internal Hex
• 07290109746944: Locator Angled 18°-1mm Length Regular 2.42 Internal Hex
• 07290109746937: Locator Angled 18°-0.5mm Length Regular 2.42 Internal Hex
• 07290109746920: Titanium Housing For Locator
• 07290109746913: Silicone Cap For Locator Hard (2.7)
• 07290109746906: Silicone Cap For Locator Standard (1.8)
• 07290109746890: Silicone Cap For Locator Soft (1.2)
• 07290109746883: Locator Regular Platform 6mm Legnth Regular 2.42 Internal Hex
• 07290109746876: Locator Regular Platform 5mm Legnth Regular 2.42 Internal Hex
• 07290109746869: Locator Regular Platform 4mm Legnth Regular 2.42 Internal Hex
• 07290109746852: Locator Regular Platform 3mm Legnth Regular 2.42 Internal Hex