GUDIDData
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gudid Primary ID: MED610-DSG, 1KG

MED610-DSG (UDI MED610-DSG, 1KG)

Manufactured by STRATASYS LTD

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MED610-DSG - Primary ID MED610-DSG, 1KG

Device Regulatory Overview

The MED610-DSG (Model/Catalog Number: MED610-DSG, 1KG) is a medical device manufactured by STRATASYS LTD. This product is indexed under FDA Product Code / Category Classification NDP within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2091-2025 View Full Alert →

TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2094-2025 View Full Alert →

TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2090-2025 View Full Alert →

TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
MED610-DSG, 1KG
Product Code / EMDN
NDP
Device Name
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.
Database Sync Date
2026-08-09 09:18:16

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of MED610-DSG?

The registered manufacturer of record for MED610-DSG is STRATASYS LTD.

What is the Primary UDI-DI identifier for MED610-DSG?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MED610-DSG, 1KG.

What classification code is assigned to this device?

This device is registered under product classification code NDP.

Similar Classification Devices (NDP)

Other Devices by STRATASYS LTD

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