Device
The Rodney Aligner Seater by Gestenco ensures that your aligners fit securely and correctly, optimizing treatment efficiency while making handling more hygienic and convenient.
Manufacturer
Gestenco International AB
Gestenco International AB
Model: RAS-004
DI: 07333117010369
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
The Rodney Aligner Seater by Gestenco ensures that your aligners fit securely and correctly, optimizing treatment efficiency while making handling more hygienic and convenient.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5ec6d705-9b2f-4b81-99f5-052417866f13
Distribution Status:
In Commercial Distribution
DUNS Number:
354936098
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:
07333117010369
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63676
Name: Orthodontic aligner/retainer seater, single-use
Definition:
A small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.
FDA Product Codes
DZN
Instruments, Dental Hand