Device
The product is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and preformed denture teeth to be used in a denture.
Manufacturer
Hangzhou SHINING3D Dental Technology Co., Ltd.
Hangzhou SHINING3D Dental Technology Co., Ltd.
Model: CX200-A1 (0.5kg/bottle)
DI: 06975338701063
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
The product is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and preformed denture teeth to be used in a denture.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
76927ef6-409a-4a9b-b241-5b27541b3da7
Distribution Status:
In Commercial Distribution
DUNS Number:
406871432
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
06975338701063
Type:
Primary
Issuing Agency:
GS1
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
EBG
Crown And Bridge, Temporary, Resin
PZY
Additively Manufactured, Preformed, Resin Denture Tooth
Premarket Submissions
Submission Number:
K261261
Supplement Number:
000