Pastel 11646

GUDID D950116461

Prophy angle, disposable, soft cup, 100 box

LARES RESEARCH

Dental material application tool, single-use

• Primary Device ID: D950116461
• NIH Device Record Key: 3cd4b27c-576b-4fa9-b140-b22bdcb2eb49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pastel
• Version Model Number: Prophy angle
• Catalog Number: 11646
• 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: 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: true
• 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
• 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	D950116461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973062

FDA Product Code

• EFA: Handpiece, Belt And/Or Gear Driven, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-12
• Device Publish Date: 2025-05-02

On-Brand Devices [Pastel]

• D950116481: Prophy Paste, Coarse Grit, Mint, 200 box
• D950116471: Prophy Paste, Medium Grit, Mint, 200 box
• D950116461: Prophy angle, disposable, soft cup, 100 box