H-0600 Resin

GUDID 00850061175151

H-0600 Resin - 5L Cartridge

FORMLABS OHIO INC.

Dental appliance fabrication material, resin

• Primary Device ID: 00850061175151
• NIH Device Record Key: 1b607651-ba94-40ed-ac81-78cf1fb21a57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H-0600 Resin
• Version Model Number: RS-RPS-H6PR-01
• Company DUNS: 106744280
• Company Name: FORMLABS OHIO 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850061175151 [Primary]

FDA Product Code

• EBH: Material, Impression Tray, Resin

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: 2025-12-09
• Device Publish Date: 2025-12-01

Devices Manufactured by FORMLABS OHIO INC.

• 00850061175151 - H-0600 Resin: 2025-12-09H-0600 Resin - 5L Cartridge
• 00850061175151 - H-0600 Resin: 2025-12-09 H-0600 Resin - 5L Cartridge
• 00850061175007 - Premium Teeth Resin - HT Bleach: 2024-05-02 Premium Teeth Resin (HT Bleach) for cartridge v2
• 00850061175014 - Premium Teeth Resin - HT A2: 2024-05-02 Premium Teeth Resin (HT A2) for cartridge v2
• 00850061175021 - Premium Teeth Resin - HT B1: 2024-05-02 Premium Teeth Resin (HT B1) for cartridge v2
• 00850061175038 - Premium Teeth Resin - HT A3: 2024-05-02 Premium Teeth Resin (HT A3) for cartridge v2
• 00850061175069 - Custom Tray Resin: 2024-05-02 Custom Tray Resin for cartridge v2
• 00850061175076 - Dental LT Clear V2: 2024-05-02 Dental LT Clear V2 for cartridge V2
• 00850061175083 - IBT Flex Resin: 2024-05-02 IBT Flex Resin for cartridge V2