Smoothdrive 13503

GUDID D950135030

Smoothdrive 1:1 contra angle dental handpiece

LARES RESEARCH

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: D950135030
• NIH Device Record Key: 5eee1136-7c06-4009-a4a3-a5852a48a800
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smoothdrive
• Version Model Number: 1:1 Contra Angle
• Catalog Number: 13503
• Company DUNS: 009127838
• Company Name: LARES RESEARCH
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com
• Phone: 5303451767
• Email: bholderbein@laresdental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D950135030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202786

FDA Product Code

• EGS: Handpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

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

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

[D950135030]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-02
• Device Publish Date: 2025-08-25

On-Brand Devices [Smoothdrive]

• D950135030: Smoothdrive 1:1 contra angle dental handpiece
• D950135110: Smoothdrive electric dental motor control system with Fluoresce HD motor