optiprint I-B-T 385

Primary DI
04260670160305
Brand
optiprint I-B-T 385
Company
dentona AG
Model
48100
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELKTeeth, Artificial, Backing And Facing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELKTeeth, Artificial, Backing And FacingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260670160305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260670160305042606701603054260670160305

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA 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.

Contacts#

Phone, Email table
PhoneEmail
+4923155560mailbox@dentona.de

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260670160046optiprint tray480212026-06-23
04260670160053optiprint tray480252026-06-23
04260670160060optiprint tray480202026-06-23
04260670160077optiprint tray480242026-06-23
04260670160084optiprint tray480222026-06-23
04260670160091optiprint tray480262026-06-23
04260670160107optiprint tray480232026-06-23
04260670160114optiprint tray480272026-06-23
04260670160169optiprint tray 405480322026-06-23
04260670160176optiprint tray 405480332026-06-23
04260670160220optiprint guide 385480002026-06-23
04260670160237optiprint guide 385480012026-06-23
04260670160244optiprint guide 405480102026-06-23
04260670160251optiprint guide 405480112026-06-23
04260670160312optiprint I-B-T 385481012026-06-23
04260670160510dentona flexisplint533202026-06-23
04260670160527dentona flexisplint533212026-06-23
04260670160534dentona flexisplint533222026-06-23
04260670160541dentona flexisplint533252026-06-23
04260670160558dentona flexisplint533262026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260670160312optiprint I-B-T 385dentona AGELK2026-06-23
07506338322416ISOTEK, MDC DentalMDC DENTALELK2025-04-29
07506338322423ISOTEK, MDC DentalMDC DENTALELK2025-04-29
17506338322413ISOTEK, MDC DentalMDC DENTALELK2025-04-29
17506338322420ISOTEK, MDC DentalMDC DENTALELK2025-04-29
08720604633771Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633788Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633795Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633801Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633818Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633825Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08719425508924Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508948Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508955Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508962Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508979Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508986Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
00850039704178OnX Tough - Hollywood BleachSprintray, Inc.ELK2022-10-04
07506338314848Newtek, MDC DentalMDC DENTALELK2022-09-28
07506338314855Newtek, MDC DentalMDC DENTALELK2022-09-28
17506338314845Newtek, MDC DentalMDC DENTALELK2022-09-28
17506338314852Newtek, MDC DentalMDC DENTALELK2022-09-28
00850039704079OnX - BleachSprintray, Inc.ELK2022-02-28
00850039704086OnX - A1Sprintray, Inc.ELK2022-02-28
00850039704093OnX - B1Sprintray, Inc.ELK2022-02-28
08719425508672CeramillVertex-Dental B.V.ELK2019-02-06
08719425508696CeramillVertex-Dental B.V.ELK2019-02-06
08719425508702CeramillVertex-Dental B.V.ELK2019-02-06
08719425508726CeramillVertex-Dental B.V.ELK2019-02-06
08719425508689CeramillVertex-Dental B.V.ELK2019-02-05