MEDICOM DENTICARE 10067

GUDID 20686864060943

Medicom DentiCare Spin DPA, Soft Cup - Gray

AMD Medicom Inc

Dental polishing cup, single-use

• Primary Device ID: 20686864060943
• NIH Device Record Key: ead41fa1-1c94-4980-bc6f-f356cc188a1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDICOM DENTICARE
• Version Model Number: 10067
• Catalog Number: 10067
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 200
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca
• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca
• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca
• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca
• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca
• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca
• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca
• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca
• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca
• Phone: 1.800.361.2862
• Email: mdasilva@medicom.ca

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864060949 [Unit of Use]
GS1	10686864060946 [Primary]
GS1	20686864060943 [Package]; Contains: 10686864060946; Package: case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240950

FDA Product Code

• EGS: Handpiece, Contra- And Right-Angle Attachment, 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: 2026-03-05
• Device Publish Date: 2026-02-25

On-Brand Devices [MEDICOM DENTICARE ]

• 00686864061144: MEDICOM DENTICARE SWIVEL DPA, Sample Pack
• 20686864060950: Medicom DentiCare Spin DPA, Firm Cup - white
• 20686864060943: Medicom DentiCare Spin DPA, Soft Cup - Gray