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Reflect Implant System RC5013C

by Integrated Dental Systems, LLC

Reflect Implant System RC5013C is a Class II device made by Integrated Dental Systems, LLC, cleared under FDA 510(k) K180924 on 29 Mar 2019 and listed in FDA GUDID since 14 May 2020 (UDI-DI 00817773022142), active as of 22 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 22 Oct 2026

Documents

510(k) K180924

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817773022142 UDI-DI Date14 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180924 Date29 Mar 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180924 decided 29 Mar 2019 Active
  • FDA GUDID UDI-DI 00817773022142 listed 14 May 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180924
  2. Listed FDA GUDID 00817773022142

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Reflect Implant System
Generic name
Dental bone matrix implant, metallic
Model / Ref / Catalog
RC5013C
Primary DI / UDI-DI
00817773022142
510(k) Number
FDA product code
DZE
GMDN term
Dental bone matrix implant, metallic
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental bone matrix implant, metallic

Cleared under the same submission (K180924)

and 8 more cleared under K180924

Similar devices

Other devices filed under FDA product code DZE (Implant, Endosseous, Root-Form).

Other devices from Integrated Dental Systems, LLC

See all devices from Integrated Dental Systems, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)