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DELTAMED GMBH

Germany · Friedberg

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

14listed device types

Class I 5Class II 8Class III 0unclassified 1

plus 26 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 2Class II 5

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class II 3Class III 1

18 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

Class I 4IIa 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States26 registration records, 6 510(k), 0 PMA

Brazil7 confirmed, 1 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: DELTAMED GMBH · Deltamed GMBH

FDA 510(k) clearances by year

12011 · K102776

12020 · K200039

12021 · K211804

12022 · K212541

12023 · K230341

12024 · K243720

FDA listed device types

showing 8 of 14

Plate, Base, Shellac 1Maintainer, Space Preformed, Orthodontic 1Accessories, Implant, Dental, Endosseous 1Material, Impression Tray, Resin 1Agent, Polishing, Abrasive, Oral Cavity 1Sealant, Pit And Fissure, And Conditioner 1Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243720	3Delta UNlimited	2024-12-18
US	K230341	ACRIFIX	2023-04-06
US	K212541	3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix	2022-01-10
BR	80424459002	Cosmeseal	Class II
BR	80424450008	RESINA RENAMEL	Class II
BR	80424459001	Cosmecore	Class II
CA	89784	PREMENO DUO VAGINAL OVULES	Class II
CA	65114	E-Z TEMP - TEMPORARY FILLING MATERIAL	Class II
CA	73130	COMPLETE UNIVERSAL ADHESIVE SYSTEM	Class III

DELTAMED GMBH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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