Acteon

GUDID 10194665007935

Camera, C20 Handpiece, Accessories

A-DEC, INC.

Intraoral camera

• Primary Device ID: 10194665007935
• NIH Device Record Key: fe88fb6e-94b1-4cef-88a7-23dfb7b6ba89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acteon
• Version Model Number: C20
• Company DUNS: 009617473
• Company Name: A-DEC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10194665007935 [Primary]

FDA Product Code

• NRD: Unit, Operative Dental, Accessories

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: 2025-05-23
• Device Publish Date: 2025-05-15

Devices Manufactured by A-DEC, INC.

• 10194665008444 - A-dec: 2026-02-27 Kit, Control Module, Midwest, OTC
• 10194665008475 - A-dec: 2026-02-27 Kit,Midwest Controller/Motor/Medium Tubing,OTC
• 10194665008482 - A-dec: 2026-02-27 Kit,Midwest Motor w/Medium Tubing,OTC
• 10194665008499 - A-dec: 2026-02-27 Kit,Midwest Controller/Motor/Long Tubing,OTC
• 10194665008505 - A-dec: 2026-02-27 Kit,Midwest Motor w/Long Tubing,OTC
• 10194665008512 - A-dec: 2026-02-27 Kit,Midwest,Implant W/ Apex,53xpro,OTC
• 10194665008529 - A-dec: 2026-02-27 Kit,Midwest,Implant,53xpro,OTC
• 10194665008550 - A-dec: 2026-02-27 Kit,Midwest,Implant,541pro,OTC