SuperLine II FXS4007BC

SuperLine II FXS4007BC is a Class II device made by Dentium USA, cleared under FDA 510(k) K213599 on 23 Feb 2022 and listed in FDA GUDID since 31 Jan 2023 (UDI-DI D755FXS4007BC0), active as of 23 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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD755FXS4007BC0 UDI-DI	Date31 Jan 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK213599	Date23 Feb 2022Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K213599

Across registries

2 registries list this device

FDA 510(k) K213599 decided 23 Feb 2022 Active
FDA GUDID UDI-DI D755FXS4007BC0 listed 31 Jan 2023 Listed

Timeline

2 dated events

23 Feb 2022 Cleared FDA 510(k) K213599
31 Jan 2023 Listed FDA GUDID D755FXS4007BC0

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: SuperLine II
Generic name: Screw endosteal dental implant, two-piece
Model / Ref / Catalog: FXS4007BC

Primary DI / UDI-DI: D755FXS4007BC0
510(k) Number: K213599
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

MRI safety: MR Conditional

Size: Outer Diameter — 3.6 Millimeter
Length — 7 Millimeter

Other devices from Dentium USA

See all devices from Dentium USA →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (8, all answered No)