Device
1ROLL/PKG. It is used to make orthodontic aligners, retainers, mouth guards, etc.
Manufacturer
Shanghai Coherz Technology Co., Ltd.
Shanghai Coherz Technology Co., Ltd.
Model: One S+ Foil-0.76-80
DI: 06975527185100
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
1ROLL/PKG. It is used to make orthodontic aligners, retainers, mouth guards, etc.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4c503c8c-0749-4261-bd00-91825840e48c
Distribution Status:
In Commercial Distribution
DUNS Number:
613781635
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06975527185100
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58288
Name: Dental appliance fabrication material, thermoplastic
Definition:
A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.
FDA Product Codes
EBH
Material, Impression Tray, Resin
DYJ
Retainer, Screw Expansion, Orthodontic