gudid Primary ID: MED610-DSG, 4KG (J5DentaJet)

MED610-DSG (UDI MED610-DSG, 4KG (J5DentaJet))

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The MED610-DSG (Model/Catalog Number: MED610-DSG, 4KG (J5DentaJet)) 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 →

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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...

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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...

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Technical Specifications

Model Number: MED610-DSG, 4KG (J5DentaJet)
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

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{
    "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, 4KG (J5DentaJet).

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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