Deep 6952

GUDID E29969529

anterior matrices

Polydentia SA

Dental matrix band, single-use

• Primary Device ID: E29969529
• NIH Device Record Key: 50c8df3e-1fba-4eaa-8d88-fff6c2cf3b2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Deep
• Version Model Number: 6952
• Catalog Number: 6952
• Company DUNS: 481461598
• Company Name: Polydentia SA
• Device Count: 100
• 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E29969520 [Primary]
HIBCC	E29969529 [Unit of Use]

FDA Product Code

• DZN: Instruments, Dental Hand

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: 2025-05-07
• Device Publish Date: 2025-04-29

Devices Manufactured by Polydentia SA

• E29969139 - Unica Proximal: 2025-05-07 anterior matrices
• E29969149 - Unica Proximal: 2025-05-07 anterior matrices
• E29969529 - Deep: 2025-05-07anterior matrices
• E29969529 - Deep: 2025-05-07 anterior matrices
• E29969539 - Unica Proximal Deep: 2025-05-07 anterior matrices
• E29963079 - myTines GO: 2024-08-27 extremities for myClip 2.0 and myRing Forte
• E29958059 - QuickmatFIT: 2024-02-06 anatomical sectional matrices 0.04mm premolar
• E29958069 - QuickmatFIT: 2024-02-06 anatomical sectional matrices 0.04mm molar
• E29958359 - QuickmatFIT: 2024-02-06 anatomical sectional matrices 0.04mm premolar