MED610-DSG OBJ-12067

GUDID 07290018915646

MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompatible, transient use (less than 60 minutes), removable, single use dental surgical guides intended for professional dental work. The target population is all patients and populations in which a clinician has prescribed a treatment associated with dental implants.

STRATASYS LTD

Dental appliance fabrication material, resin

• Primary Device ID: 07290018915646
• NIH Device Record Key: 1a39fcd4-0403-4fff-8a09-4539891f6f5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MED610-DSG
• Version Model Number: MED610-DSG, 4KG (J5DentaJet)
• Catalog Number: OBJ-12067
• Company DUNS: 532091048
• Company Name: STRATASYS LTD
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018915646 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[07290018915646]

Moist Heat or Steam Sterilization

[07290018915646]

Moist Heat or Steam Sterilization

[07290018915646]

Moist Heat or Steam Sterilization

[07290018915646]

Moist Heat or Steam Sterilization

[07290018915646]

Moist Heat or Steam Sterilization

[07290018915646]

Moist Heat or Steam Sterilization

[07290018915646]

Moist Heat or Steam Sterilization

[07290018915646]

Moist Heat or Steam Sterilization

[07290018915646]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-17
• Device Publish Date: 2025-09-09

On-Brand Devices [MED610-DSG]

• 07290018915837: MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompa
• 07290018915646: MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompa
• 07290018915448: MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompa
• 07290018915240: MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompa
• 07290018915042: MED610-DSG is a light-curable resin intended for the fabrication of rigid, transparent, biocompa