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DiamoDent R1200

by Diamodent

DiamoDent R1200 is a Class II device made by Diamodent, cleared under FDA 510(k) K010619 on 28 Sep 2001 and listed in FDA GUDID since 29 Jun 2020 (UDI-DI D907R12000), 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) K010619

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 NumberD907R12000 UDI-DI Date29 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010619 Date28 Sep 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010619 decided 28 Sep 2001 Active
  • FDA GUDID UDI-DI D907R12000 listed 29 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010619
  2. Listed FDA GUDID D907R12000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DiamoDent
Generic name
Dental implant suprastructure, temporary, preformed, reusable
Description
Scan Body, Medical Grade PEEK & Titanium, Purple Compatible with: 4.7mm (4.5mm Platform) Screw-Vent Zimmer implants
Catalogue number
R1200
Primary DI / UDI-DI
D907R12000
510(k) Number
FDA product code
DZE
GMDN term
Dental implant suprastructure, temporary, preformed, reusable
Device class
Class II
Regulation number
872.3640
GUDID distribution status
In Commercial Distribution
Sterilisation method
Dry Heat Sterilization

Related devices

Category: Dental implant suprastructure, temporary, preformed, reusable

Cleared under the same submission (K010619)

and 8 more cleared under K010619

Similar devices

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

Other devices from Diamodent

See all devices from Diamodent →

Properties

  • Sterilise before use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)