Pristine by 3D Dental

GUDID 00817169024989

PRISTINE ULTRASONIC CLEANING TABLETS BOX/64

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Medical device cleaning agent

• Primary Device ID: 00817169024989
• NIH Device Record Key: b2aea8bf-a828-4e5b-9fcc-e374e7bdbd26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pristine by 3D Dental
• Version Model Number: PRST-UT
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817169024989 [Primary]

FDA Product Code

• MNL: Accessories, Cleaning Brushes, For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-13
• Device Publish Date: 2026-03-05

Devices Manufactured by 3D DENTAL DESIGNS AND DEVELOPMENT, LLC

• 00810126506221 - 3D Dental: 2026-04-01 Root Canal preparation Cream
• 00810126506757 - Comfortox: 2026-04-01 Comfortox Sterile syringes /with needle 0.5cc 30g x 13mm Box/100
• 00810126506764 - Comfortox: 2026-04-01 Comfortox Sterile syringes /with needle 0.5cc 29g x 8mm Box/100
• 00810126508331 - Basik by 3D Dental: 2026-03-25 Basik PGC SUTURE USP 3/0..3/8 REV CUTTING NEEDLE 24MM LENGTH Box of 12
• 00810126508348 - Basik by 3D Dental: 2026-03-25 Basik PGC SUTURE USP 2/0..3/8 REV CUTTING NEEDLE 24MM LENGTH Box of 12
• 10817169023019 - Basik by 3D Dental: 2026-03-25 Baskik PGLA BPGLA467 USP 0 - 1/2 circle Revcut 36mm
• 00817169021483 - 3D Dental - Dream: 2026-03-25 DREAM FLUORIDE VARNISH MELON..40 ML BOX/50
• 00817169023005 - Basik by 3D Dental: 2026-03-25 Basik PGLA USP 2/0 - 3/8 Rev Cut 24.mm