Brånemark System® 32630

GUDID 07332747013030

Bmk Syst Zygoma Pilot Drill 3.5 mm

Nobel Biocare AB

Fluted surgical drill bit, single-use, non-sterile

• Primary Device ID: 07332747013030
• NIH Device Record Key: c62a6696-8844-4bc1-a129-8ea87b8686d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brånemark System®
• Version Model Number: 32630
• Catalog Number: 32630
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• Device Count: 1
• DM Exempt: true
• 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(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747013030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990846

FDA Product Code

• DZI: DRILL, BONE, POWERED

Sterilization

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

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

[07332747013030]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-31
• Device Publish Date: 2016-09-17

On-Brand Devices [Brånemark System®]

• 07332747112467: Brånemark System® Zygoma Angled Multi-unit Abutment Screw
• 07332747073805: Brånemark System Counterbore Mk III RP, long shaft
• 07332747073782: Brånemark System Counterbore Mk III RP
• 07332747073775: Brånemark System Counterbore Mk III NP
• 07332747029345: Brånemark System® Twist drill Ø 3.15 mm 7-15 mm
• 07332747029260: Brånemark System® Counterbore short
• 07332747024708: Twist Drill Brånemark System® RP 1.6 mm
• 07332747024692: Twist Drill Brånemark System® NP 1.3 mm
• 07332747023053: Screw Tap Repair Brånemark System® WP
• 07332747023046: Screw Tap Repair Brånemark System® RP
• 07332747023039: Screw Tap Repair Brånemark System® NP
• 07332747013528: Brånemark System® Zygoma TiU 52.5mm
• 07332747013511: Brånemark System® Zygoma TiU 50mm
• 07332747013504: Brånemark System® Zygoma TiU 47.5mm
• 07332747013498: Brånemark System® Zygoma TiU 45mm
• 07332747013481: Brånemark System® Zygoma TiU 42.5mm
• 07332747013474: Brånemark System® Zygoma TiU 40mm
• 07332747013467: Brånemark System® Zygoma TiU 35mm
• 07332747013450: Brånemark System® Zygoma TiU 30mm
• 07332747013436: Brånemark System® Zygoma Round Bur
• 07332747013344: Brånemark System Mk IV TiU WP 5.0x8.5mm
• 07332747013337: Brånemark System Mk IV TiU WP 5.0x7mm
• 07332747013320: Brånemark System Mk IV TiU WP 5.0x15mm
• 07332747013313: Brånemark System Mk IV TiU WP 5.0x13mm
• 07332747013306: Brånemark System Mk IV TiU WP 5.0x11.5mm
• 07332747013290: Brånemark System Mk IV TiU WP 5.0x10mm
• 07332747013283: Brånemark System Mk IV TiU RP 4.0x8.5mm
• 07332747013276: Brånemark System Mk IV TiU RP 4.0x7mm
• 07332747013269: Brånemark System Mk IV TiU RP 4.0x18mm
• 07332747013252: Brånemark System Mk IV TiU RP 4.0x15mm
• 07332747013245: Brånemark System Mk IV TiU RP 4.0x13mm
• 07332747013238: Brånemark System Mk IV TiU RP 4.0x11.5mm
• 07332747013221: Brånemark System Mk IV TiU RP 4.0x10mm
• 07332747013078: Bmk Syst Zygoma Twist Drill 3.5 mm short
• 07332747013061: Bmk Syst Zygoma Twist Drill 3.5 mm
• 07332747013054: Bmk Syst Zygoma Twist Drill 2.9 mm short
• 07332747013047: Bmk Syst Zygoma Pilot Drill 3.5 mm short
• 07332747013030: Bmk Syst Zygoma Pilot Drill 3.5 mm
• 07332747009682: Brånemark System® Second Stage Surg Kit. The kit includes manual Bone Mills and Cover Screw Mi
• 07332747006414: Bmk Syst Zygoma Twist Drill 2.9 mm
• 07332747005264: Guided Start Drill/Counterbore Brånemark System® WP Ø6
• 07332747005257: Guided Start Drill/Counterbore Brånemark System® WP Ø5
• 07332747005240: Guided Start Drill/Counterb Brånemark System® RP
• 07332747005233: Guided Start Drill/Counterbore Brånemark System® NP
• 07332747005189: Brånemark System® Counterbore WP
• 07332747005172: Brånemark System® Counterbore RP
• 07332747005165: Brånemark System® Counterbore NP
• 07332747005028: Bone Mill with Guide Brånemark System® WP Ø6.5
• 07332747005011: Bone Mill with Guide Brånemark System® RP Ø5.1
• 07332747005004: Bone Mill with Guide Brånemark System® NP Ø4.5