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Dsd-Retain

by Park Dental Research Corp

Dsd-Retain is a Class II device made by Park Dental Research Corp, cleared under FDA 510(k) K180648 on 8 Jan 2019 and listed in FDA GUDID since 17 Jun 2026 (UDI-DI D769DSDRETAIN0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K180648

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD769DSDRETAIN0 UDI-DI Date17 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180648 Date8 Jan 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180648 decided 8 Jan 2019 Active
  • FDA GUDID UDI-DI D769DSDRETAIN0 listed 17 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180648
  2. Listed FDA GUDID D769DSDRETAIN0

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dsd
Generic name
Orthodontic progressive aligner
Model / reference
DSD-RETAIN
Primary DI / UDI-DI
D769DSDRETAIN0
510(k) Number
FDA product code
NXC
GMDN term
Orthodontic progressive aligner
Device class
Class II
Regulation number
872.5470
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K180648)

and 5 more cleared under K180648

Similar devices

Other devices filed under FDA product code NXC (Aligner, Sequential).

Other devices from Park Dental Research Corp

See all devices from Park Dental Research Corp →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)