myTines Prime 6892

GUDID E29968929

Polydentia SA

Dental matrix band retainer

• Primary Device ID: E29968929
• NIH Device Record Key: d76cb4cd-77d4-4337-af27-fec462ec97e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myTines Prime
• Version Model Number: 6892
• Catalog Number: 6892
• Company DUNS: 481461598
• Company Name: Polydentia SA
• Device Count: 6
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E29968920 [Primary]
HIBCC	E29968929 [Unit of Use]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

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

[E29968929]

Moist Heat or Steam Sterilization

[E29968929]

Moist Heat or Steam Sterilization

[E29968929]

Moist Heat or Steam Sterilization

[E29968929]

Moist Heat or Steam Sterilization

[E29968929]

Moist Heat or Steam Sterilization

[E29968929]

Moist Heat or Steam Sterilization

[E29968929]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-24
• Device Publish Date: 2025-06-16

Devices Manufactured by Polydentia SA

• E29950029 - wood wedges: 2025-06-24
• E2995018MN9 - Orange wood wedges: 2025-06-24
• E2995018PLUS9 - Orange wood wedges: 2025-06-24
• E2995018S9 - Orange wood wedges: 2025-06-24
• E29968900 - myQuickmat Prime Kit: 2025-06-24
• E29968919 - myRing Prime: 2025-06-24
• E29968929 - myTines Prime: 2025-06-24
• E29968929 - myTines Prime: 2025-06-24
• E29968939 - Quickmat Prime: 2025-06-24