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Roydent PL208

by Roydent Dental Products Inc

Roydent PL208 is a Class I device made by Roydent Dental Products Inc, listed in FDA GUDID since 7 Oct 2016 (UDI-DI D809PL2081), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD809PL2081 UDI-DI Date7 Oct 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Roydent
Generic name
Dental root surface conditioner
Model / Ref / Catalog
PL208
Primary DI / UDI-DI
D809PL2081
FDA product code
EKL, KIF
GMDN term
Dental root surface conditioner
Device class
Class I
Regulation number
872.3840, 872.3820
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 2 Fluid Ounce

Related devices

Category: Dental root surface conditioner

Other devices from Roydent Dental Products Inc

See all devices from Roydent Dental Products Inc →

Properties

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