Consulting Wallah › Device Explorer › Other devices › Orthodontic aligner/retainer seater, single-use
Device Explorer · FDA GUDID · GMDN 63676

Orthodontic aligner/retainer seater, single-use

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, allow

US‑registered devices67in commercial distribution
Companies14labelers on GUDID
Single‑use70%of device records
Sterile0%labelled sterile
Prescription27%Rx‑only share
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Share of device records

Dentsply Sirona Orthodontics Inc.1218%
Jmu Dental, Inc913%
Plasdent Corporation710%
Practicon, Inc.710%
Gc Orthodontics America Inc.69%
Young Innovations, Inc.57%
Ortho Technology, Inc.57%
Gestenco International Ab46%

Top labelers

CompanyDevicesShare
Dentsply Sirona Orthodontics Inc.1218%
Jmu Dental, Inc913%
Plasdent Corporation710%
Practicon, Inc.710%
Gc Orthodontics America Inc.69%
Young Innovations, Inc.57%
Ortho Technology, Inc.57%
Gestenco International Ab46%
Glenroe, Llc46%
Maxill, Inc.34%
American Medical & Hospital Supply Co., Inc.23%
Access Dental Lab, Llc11%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Rodney Aligner SeatersRodney Aligner Seaters, melonRodney Aligner Seaters, lemonRodney Aligner Seaters, mintPlatypusORTHO ALIGNER TRAY SEATERSPlasdentAmtouch Aligner ChewiesALIGNER SEATER PURPLEYoung SpecialtiesClenchyRodneyChewiesJMUChewies ™SMILEGOODS ALIGNER CHEWIES ASSORTED

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ECSPusher, Band, Orthodontic25
ECSPUSHER, BAND, ORTHODONTIC22
ECQAligner, Bracket, Orthodontic8
NRDUnit, Operative Dental, Accessories7
DZNInstruments, Dental Hand4
ECRSetter, Band, Orthodontic1

GMDN & GCC registration

  • GMDN code 63676 · non‑implantable
  • Single‑use 70% · sterile 0% · Rx‑only 27% · OTC 18%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many orthodontic aligner/retainer seater, single-use products are registered in the US?

67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic aligner/retainer seater, single-use", from 14 companies. The largest labeler is Dentsply Sirona Orthodontics Inc. with 18% of records.

Which FDA product codes apply?

ECS (Pusher, Band, Orthodontic), ECS (PUSHER, BAND, ORTHODONTIC), ECQ (Aligner, Bracket, Orthodontic), NRD (Unit, Operative Dental, Accessories)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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