Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030938

FEI Number

3004586882

Entity Name

DIRECTA AB

City/State/Country

UPPLANDS VAESBY Stockholm, SE

Establishment Address

PO BOX 723, FINVIDS VAG 8, UPPLANDS VAESBY Stockholm 194 27, SE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

DIRECTA AB (Owner Number: 9004750)

Owner / Operator Contact Address

P.O.BOX 723, FINVIDS VAG 8, UPPLANDS VASBY, SE-NOTA 194 27, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241131

PMA Number

N/A

All Registered Proprietary Names

Supra disc K-reamer FenderMate Directa Strips ProxyPal FenderMatePrime DryDent Sublingual, DryDent Parotid Advance Dry Angle Tips IWANSSON MEASURING DEVICE ContacEZ Incremental Thickness Gauge S5 System S5 Rotary Files Starter Pack Paste Filler Big Apical Files S1 Plus Sendoline S3 System Rondell Directa Polycarbonate Crowns Strip Crown Forms Polycarbonate Crowns Temporary FullForm Crown Forms CoForm Crown Forms Ceramir Pediatric Crown RAINBOW RUBBER DAM FRAME TRAY CLEANER Barb Broaches Luxator® sharpening stone Luxator® brand Ceramir Bioceramic Implant Cement QuikCap Ceramir Crown & Bridge QuikMix Ceramir Crown & Bridge QuikCap Etchant Gel Snap-on Discguard Calasept Paste Needle, CalaseptPlus Flexi-Needle, Calasept Irrigation Needle Physics Forceps and Bumper Guards PrepSure Barman's Wedges ProphyCare SendoSeal MTA SendoCem MTA Calasept, CalaseptPlus CAMO DENTAL SPLINT ContacEZ Strip Tray PractiPal INSTRUMENT TRAY SYSTEM ROTOSTAND ProphyCare ProphyCup NiTi Spreader Finger Spreader Ceramir CAD/CAM block

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2021-09-13
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2021-12-16
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2007-11-19
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2016-02-22
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	1985-08-27
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	1985-08-27
QJC	Plaque Disclosing Agent	Dental	Class 1	872.6855	2026-03-24
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2002-07-11
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2002-07-11
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1985-08-27
EKW	Broach, Endodontic	Dental	Class 1	872.4565	2021-02-09
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2002-07-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2024-01-03
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-10-23
EEJ	Guard, Disk	Dental	Class 1	872.6010	2021-09-15
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2002-07-11
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2002-07-11
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2024-06-24
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2024-12-12
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2016-02-16
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2002-07-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1985-08-27
EJL	Bur, Dental	Dental	Class 1	872.3240	2002-07-11
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2002-07-11
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2021-02-09
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-12-12

Official Correspondent

Tomas Skeppmark

US Agent Details

Yasily Ogando Roa Business: Parkell Inc. Email: yogando@parkell.com Phone: (631) 3891560

Related Public Records

Same Entity

DIRECTA AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
2523990	SPRING HEALTH PRODUCTS, INC.	NORRISTOWN, PA, US
1526534	Sterigenics US, LLC	Lewis Center, OH, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
3003444492	PRIMA DENTAL GROUP	GLOUCESTER Gloucestershire, GB
9615845	RECO-DENT INTL. CO., LTD.	NEW TAIPEI CITY, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030938. Last updated year: 2026. Please use registration number 8030938 when referencing this establishment in official correspondence.