Directa AB
Newtown, CT, US
DIRECTA AB appears in FDA device records in Newtown, CT. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Directa AB in 2015.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8030938 | 3004586882 | DIRECTA AB | PO BOX 723, UPPLANDS VAESBY Stockholm 194 27 SE | 2026 | and 22 more, listed in full below |
| 3011175550 | 3011175550 | DIRECTA INC | 64 Barnabas Rd, Newtown, CT 06470 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- EJRAgent, Polishing, Abrasive, Oral Cavity
- EKWBroach, Endodontic
- EJLBur, Dental
- EMACement, Dental
- ELZCrown, Preformed
- EHKCup, Prophylaxis
- EIEDam, Rubber
- DZADrill, Dental, Intraoral
- EMJElevator, Surgical, Dental
- EKSFile, Pulp Canal, Endodontic
- EJEFrame, Rubber Dam
- EILGauge, Depth, Instrument, Dental
- EEJGuard, Disk
- EJBHandle, Instrument, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EGZHolder, Film, X-Ray
- DZPInstrument, Diamond, Dental
- DZNInstruments, Dental Hand
- EJKLiner, Cavity, Calcium Hydroxide
- EBFMaterial, Tooth Shade, Resin
- EFHPaper, Articulation
- QJCPlaque Disclosing Agent
- EKRPlugger, Root Canal, Endodontic
- ELRPost, Root Canal
- BRWProtector, Dental
- EKPReamer, Pulp Canal, Endodontic
- KIFResin, Root Canal Filling
- JEPRetainer, Matrix
- EKKSpreader, Pulp Canal Filling Material, Endodontic
- EHMStrip, Polishing Agent
- EHYTray, Impression, Preformed
- FSMTray, Surgical, Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain