Device
Content: 1 bottle. Mass: 500g. Liquid resin intended for use with stereolithography (SLA) 3D printers, is used for the fabrication of burnout patterns employed in casting or pressi...
Manufacturer
ZIRKONZAHN SRL
ZIRKONZAHN SRL
Model: ZBAC6705WHI
DI: D800ZBAC6705WHI0
Status: New
MRI: MR Safe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Content: 1 bottle. Mass: 500g. Liquid resin intended for use with stereolithography (SLA) 3D printers, is used for the fabrication of burnout patterns employed in casting or pressing techniques for manufacturing dental structures.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e3a1d6b5-068b-4f15-ac0a-5ff01a3b9e2e
Distribution Status:
In Commercial Distribution
DUNS Number:
564251911
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
D800ZBAC6705WHI0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 16730
Name: Dental appliance fabrication material, resin
Definition:
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.
FDA Product Codes
EGD
Wax, Dental, Intraoral