3Delta UNlimited 1613110

by DeltaMed GmbH

3Delta UNlimited 1613110 is a Class II device made by DeltaMed GmbH, cleared under FDA 510(k) K243720 on 18 Dec 2024 and listed in FDA GUDID since 14 Mar 2025 (UDI-DI EDEL16131100), 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	NumberEDEL16131100 UDI-DI	Date14 Mar 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK243720	Date18 Dec 2024Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K243720

Across registries

2 registries list this device

FDA 510(k) K243720 decided 18 Dec 2024 Active
FDA GUDID UDI-DI EDEL16131100 listed 14 Mar 2025 Listed

Timeline

2 dated events

18 Dec 2024 Cleared FDA 510(k) K243720
14 Mar 2025 Listed FDA GUDID EDEL16131100

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: 3Delta UNlimited
Generic name: Dental appliance fabrication material, combination-material
Model / Ref / Catalog: 1613110

Primary DI / UDI-DI: EDEL16131100
510(k) Number: K243720
FDA product code: EBF, EBI, EBG, PZY
GMDN term: Dental appliance fabrication material, combination-material

Device class: Class II
Regulation number: 872.3690, 872.3760, 872.3770, 872.3590
GUDID distribution status: In Commercial Distribution

Other devices from DeltaMed GmbH

FuturaPrint Composite C1

Class IIa
RS VIVO Crown B1

Class IIa
3Delta Crown C3

Class IIa
picobello plus

Class I

See all devices from DeltaMed GmbH →

Properties

Single use
Prescription use
Lot / batch number
Expiration date

Other properties (11, all answered No)