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Odontit RA5008

by Odontit S.A.

Odontit RA5008 is a screw endosteal dental implant (FDA Class II; FDA product code DZE, Implant, Endosseous, Root-Form) made by Odontit S.A., listed in FDA GUDID since 27 May 2019 (UDI-DI D914RA50080), 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 NumberD914RA50080 UDI-DI Date27 May 2019ListedStatusListed 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  • Withdrawn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
Odontit
Generic name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
RA5008
Primary DI / UDI-DI
D914RA50080
FDA product code
DZE
GMDN term
Screw endosteal dental implant, two-piece
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Screw endosteal dental implant, two-piece

Similar devices in this category

Other devices filed under Screw endosteal dental implant, two-piece.

Other devices from Odontit S.A.

See all devices from Odontit S.A. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)