Pk1

GUDID 00810126381248

Digital Dental Laboratories, Inc

Orthodontic retainer

• Primary Device ID: 00810126381248
• NIH Device Record Key: 359f63c3-4622-45cb-bdd6-fdb0c73206e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pk1
• Version Model Number: 1248
• Company DUNS: 251537143
• Company Name: Digital Dental Laboratories, 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: true
• Lot Batch: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810126381248 [Primary]

FDA Product Code

• ECN: Clamp, Wire, Orthodontic

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

Devices Manufactured by Digital Dental Laboratories, Inc

• 00810126381118 - Nance - Hor Rem: 2026-03-06
• 00810126380159 - Set Full Denture: 2026-03-05
• 00810126380166 - Finish Full Denture: 2026-03-05
• 00810126380173 - Finish Denture - 1-3 Teeth: 2026-03-05
• 00810126380180 - Finish Denture - 4-7 Teeth: 2026-03-05
• 00810126380197 - Finish Denture - 8+ teeth: 2026-03-05
• 00810126380203 - Flipper - 1 to 2 teeth: 2026-03-05
• 00810126380210 - Flipper - 3+ teeth: 2026-03-05