Device
Rodin Palette Refill, Red-Pink Light Cure Acrylic, 3 x 1mL Syringe
Manufacturer
Pac-Dent, Inc.
Pac-Dent, Inc.
Model: 3DR-PLT-RPK
DI: 00810184450030
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Rodin Palette Refill, Red-Pink Light Cure Acrylic, 3 x 1mL Syringe
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
447205c1-999a-4ffd-af40-ee61bd0b4b93
Distribution Status:
In Commercial Distribution
DUNS Number:
080104787
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810184450030
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34771
Name: Dental unfilled resin sealant/coating
Definition:
A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.
FDA Product Codes
EBD
Coating, Filling Material, Resin