One Plus

GUDID 00850057092974

ONE Bite Registration Material 50ml, 4 Cartridges, Super Fast Set

Hexa Dental

Silicone dental impression material

• Primary Device ID: 00850057092974
• NIH Device Record Key: 2dba0ff5-73e5-4781-8613-d5134a487669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Plus
• Version Model Number: JB-0011
• Company DUNS: 096955608
• Company Name: Hexa Dental
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00850057092974 [Primary]

FDA Product Code

• ELW: Material, Impression

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: 2026-01-29
• Device Publish Date: 2026-01-21

On-Brand Devices [One Plus]

• 00850057092912: ONE VPS Impression Material 50ml, 4 Cartridges, Heavy Body, Regular Set
• 00850057092905: ONE VPS Impression Material 50ml, 4 Cartridges, Heavy Body, Fast Set
• 00850057092899: ONE VPS Impression Material 50ml, 4 Cartridges, Light Body, Regular Set
• 00850057092882: ONE VPS Impression Material 50ml, 4 Cartridges, Light Body, Fast Set
• 00850079280021: ONE Bite Registration Material 50ml, 100 Cartridges BULK, SuperFast Set
• 00850079280007: ONE Bite Registration Material 50ml, 100 Cartridges BULK, Fast Set
• 00850057092981: ONE Bite Registration Material 50ml, 4 Cartridges, Regular Set
• 00850057092974: ONE Bite Registration Material 50ml, 4 Cartridges, Super Fast Set
• 00850057092967: ONE Bite Registration Material 50ml, 4 Cartridges, Fast Set
• 00850057092950: ONE VPS Impression Material 50ml, 100 Cartridges, BULK Light Body, Regular Set
• 00850057092943: ONE VPS Impression Material 50ml, 100 Cartridges, BULK Light Body, Fast Set
• 00850057092936: ONE VPS Impression Material 50ml, 100 Cartridges, BULK Heavy Body, Regular Set
• 00850057092929: ONE VPS Impression Material 50ml, 100 Cartridges, BULK Heavy Body, Fast Set
• 00085007928014: ONE Bite Registration Material 50ml, 100 Cartridges BULK, Regular Set