Home GUDID 04260670160312
optiprint I-B-T 385
Primary DI 04260670160312
Brand optiprint I-B-T 385
Company dentona AG
Model 48101
Published 2026-06-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true
Product Codes# Code, Name table Code Name ELK Teeth, Artificial, Backing And Facing
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ELK Teeth, Artificial, Backing And Facing Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04260670160312 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260670160312 04260670160312 4260670160312
GMDN Terms# Term, Definition table Term Definition Dental appliance fabrication material, resin A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
Regulatory Flags# DUNS number 328651799 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04260670160305 optiprint I-B-T 385 dentona AG ELK 2026-06-23 07506338322416 ISOTEK, MDC Dental MDC DENTAL ELK 2025-04-29 07506338322423 ISOTEK, MDC Dental MDC DENTAL ELK 2025-04-29 17506338322413 ISOTEK, MDC Dental MDC DENTAL ELK 2025-04-29 17506338322420 ISOTEK, MDC Dental MDC DENTAL ELK 2025-04-29 08720604633771 Vertex-Dental BV Vertex-Dental B.V. ELK 2024-04-19 08720604633788 Vertex-Dental BV Vertex-Dental B.V. ELK 2024-04-19 08720604633795 Vertex-Dental BV Vertex-Dental B.V. ELK 2024-04-19 08720604633801 Vertex-Dental BV Vertex-Dental B.V. ELK 2024-04-19 08720604633818 Vertex-Dental BV Vertex-Dental B.V. ELK 2024-04-19 08720604633825 Vertex-Dental BV Vertex-Dental B.V. ELK 2024-04-19 08719425508924 Vertex-Dental BV Vertex-Dental B.V. ELK 2023-08-03 08719425508948 Vertex-Dental BV Vertex-Dental B.V. ELK 2023-08-03 08719425508955 Vertex-Dental BV Vertex-Dental B.V. ELK 2023-08-03 08719425508962 Vertex-Dental BV Vertex-Dental B.V. ELK 2023-08-03 08719425508979 Vertex-Dental BV Vertex-Dental B.V. ELK 2023-08-03 08719425508986 Vertex-Dental BV Vertex-Dental B.V. ELK 2023-08-03 00850039704178 OnX Tough - Hollywood Bleach Sprintray, Inc. ELK 2022-10-04 07506338314848 Newtek, MDC Dental MDC DENTAL ELK 2022-09-28 07506338314855 Newtek, MDC Dental MDC DENTAL ELK 2022-09-28 17506338314845 Newtek, MDC Dental MDC DENTAL ELK 2022-09-28 17506338314852 Newtek, MDC Dental MDC DENTAL ELK 2022-09-28 00850039704079 OnX - Bleach Sprintray, Inc. ELK 2022-02-28 00850039704086 OnX - A1 Sprintray, Inc. ELK 2022-02-28 00850039704093 OnX - B1 Sprintray, Inc. ELK 2022-02-28 08719425508672 Ceramill Vertex-Dental B.V. ELK 2019-02-06 08719425508696 Ceramill Vertex-Dental B.V. ELK 2019-02-06 08719425508702 Ceramill Vertex-Dental B.V. ELK 2019-02-06 08719425508726 Ceramill Vertex-Dental B.V. ELK 2019-02-06 08719425508689 Ceramill Vertex-Dental B.V. ELK 2019-02-05