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Tryon SC 3585

by S.I.N. - Sistema DE Implante Nacional S.A.

Ref SC 3585Model DENTAL IMPLANTS WITHOUT HYDROXYAPATITE

Tryon SC 3585 is a device classified as Class IIb in the EU and Class II in the US made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 999520000001JG), cleared under FDA 510(k) K200992 on 17 Nov 2020 and listed in FDA GUDID since 28 Jun 2022 (UDI-DI 07899995270320), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200992

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000001JG Basic UDI-DI 07899995270320UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995270320 UDI-DI Date28 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200992 Date17 Nov 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 999520000001JG registered 18 Aug 2026 Active
  • FDA 510(k) K200992 decided 17 Nov 2020 Active
  • FDA GUDID UDI-DI 07899995270320 listed 28 Jun 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200992
  2. Listed FDA GUDID 07899995270320
  3. Registered EUDAMED 999520000001JG

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Imp. Tryon Co CM11.5° Ø3.5x8.5mm EUDAMED
Tryon GUDID
Generic name
Screw endosteal dental implant, one-piece
Device name
Implant Tryon | Implant Strong Sw | Implant Epikut
Model / Ref / Catalog
SC 3585, DENTAL IMPLANTS WITHOUT HYDROXYAPATITE
Primary DI / UDI-DI
07899995270320
Basic UDI-DI
999520000001JG
510(k) Number
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Screw endosteal dental implant, one-piece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Screw endosteal dental implant, one-piece

Cleared under the same submission (K200992)

and 8 more cleared under K200992

Other devices from S.I.N. - Sistema DE Implante Nacional S.A.

See all devices from S.I.N. - Sistema DE Implante Nacional S.A. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)