DLC Step Drill 3.8/3.4mm (6-13mmL) SD3.8CS

GUDID 10841307124788

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Fluted surgical drill bit, reusable

• Primary Device ID: 10841307124788
• NIH Device Record Key: 1f25d368-a658-4a10-8a80-ae0f8e7a92ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DLC Step Drill 3.8/3.4mm (6-13mmL)
• Version Model Number: SD3.8CS
• Catalog Number: SD3.8CS
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• 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: 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: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307124788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200265

FDA Product Code

• DZI: Drill, Bone, Powered

Sterilization

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

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

[10841307124788]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-18
• Device Publish Date: 2020-08-10

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

• 10841307111627 - Legacy™ Plastic Engaging Temporary Abutment: 2024-12-23
• 10841307111634 - Legacy™ Plastic Engaging Temporary Abutment: 2024-12-23
• 10841307111641 - Legacy™ Plastic Engaging Temporary Abutment: 2024-12-23
• 10841307111696 - Legacy™ Plastic Temporary Abutment: 2024-12-23
• 10841307103585 - ReActive® Implant: 2024-12-20 Ø3.7 x 8 Platform 3.5mmD
• 10841307103592 - ReActive® Implant: 2024-12-20 Ø3.7 x 8 Platform 3.5mmD
• 10841307103608 - ReActive® Implant: 2024-12-20 Ø3.7 x 8 Platform 3.5mmD
• 10841307103615 - ReActive® Implant: 2024-12-20 Ø3.7 x 8 Platform 3.5mmD