Quantum 200-135-014 HA

GUDID D825200135014HA0

Thread Implant 3.5 X 14 HA

QUANTUM BIOENGINEERING LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: D825200135014HA0
• NIH Device Record Key: 720d20bf-c820-4d48-9857-687f40be7f07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum
• Version Model Number: 200-135-014 HA
• Catalog Number: 200-135-014 HA
• Company DUNS: 797604456
• Company Name: QUANTUM BIOENGINEERING LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com
• Phone: +1(954)474-2556
• Email: info@quantumimplants.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 14 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D825200135014HA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002241

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

[D825200135014HA0]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-12

On-Brand Devices [Quantum]

• D82596015010030: Rapid 5.0 -3
• D8259601501000: Rapid 5.0
• D82596014010030: Rapid 4.0 -3
• D8259601401000: Rapid 4.0
• D82596013510030: Rapid 3.5 -3
• D8259601351000: Rapid 3.5
• D82596013010030: Rapid 3.0 -3
• D8259601301000: Rapid 3.0
• D82596011102030: Rapid Holding Screw -3
• D8259601110200: Rapid Holding Screw
• D82596002000030: Rapid Lock -3
• D8259600200000: Rapid Lock
• D82560016010030: Healing Cap 6.0 3L
• D82560015010030: Healing Cap 5.0 3L
• D8256001501000: Healing Cap 5.0 L
• D8256001500250: Hex Abutment 5.0-25°
• D8256001500150: Hex Abutment 5.0-15°
• D8256001500000: Hex Abutment 5.0-0°
• D82560014010030: Healing Cap 4.0 3L
• D8256001401000: Healing Cap 4.0 L
• D8256001400250: Hex Abutment 4.0-25°
• D8256001400150: Hex Abutment 4.0-15°
• D8256001400000: Hex Abutment 4.0-0°
• D82560013510030: Healing Cap 3.5 3L
• D8256001351000: Healing Cap 3.5 L
• D8256001350250: Hex Abutment 3.5-25°
• D8256001350150: Hex Abutment 3.5-15°
• D8256001350000: Hex Abutment 3.5-0°
• D8256001110000: Hex Abutment Locking Screw
• D8255126000000: Q Fit Analog
• D82551226002530: Q Fit Abutment 5.0-25° 3L
• D8255122600250: Q Fit Abutment 5.0-25° L
• D82551226001530: Q Fit Abutment 5.0-15° 3L
• D8255122600150: Q Fit Abutment 5.0-15° L
• D82551226000030: Q Fit Abutment 5.0-0° 3L
• D8255122600000: Q Fit Abutment 5.0-0° L
• D82551216002530: Q Fit Abutment 5.0- 25° 3R
• D8255121600250: Q Fit Abutment 5.0- 25° R
• D82551216001530: Q Fit Abutment 5.0-15° 3R
• D8255121600150: Q Fit Abutment 5.0-15° R
• D82551216000030: Q Fit Abutment 5.0-0° 3R
• D8255121600000: Q Fit Abutment 5.0-0° R
• D82551206002530: Q Fit Abutment 5.0-25° 3S
• D8255120600250: Q Fit Abutment 5.0-25° S
• D82551206001530: Q Fit Abutment 5.0-15° 3S
• D8255120600150: Q Fit Abutment 5.0- 15° S
• D82551206000030: Q Fit Abutment 5.0-0° 3S
• D8255120600000: Q Fit Abutment 5.0-0° S
• D8255120000000: Q Fit Retention Coping
• D8255045000000: Res-Q Analog