Data / Medical devices / Czechia / SpofaDental a.s.
SpofaDental a.s.: FDA-registered device maker in Jicin, Czechia, 3 510(k) clearances
SpofaDental a.s. is registered with the FDA (registration 3007743883) in Jicin, Czechia. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 5, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007743883
- Address
- Markova 238, Jicin, Czechia, 506 01
- Owner or operator
- SYBRON DENTAL SPECIALTIES, INC. (9029565)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 19, 1996
- Registered through
- 2027
- Brand names listed
- AXIS Laminate Veneer Set, Acrylic Adjustment Logic Set, Adapt Luciwedge, Bite Adjustment Logic Set, Blue Cervical Foils, Blue Cervical Matrices, Blue Transparent Molar & Premolar Bands, Blue View Grip Strips and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Rubber Dam | EEF | 1 | Contract manufacturer | accessdata.fda.gov |
| Cord, Retraction | MVL | U | Contract manufacturer | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer | accessdata.fda.gov |
| Light, Surgical Headlight | EBA | 1 | Contract manufacturer | accessdata.fda.gov |
| Loupe, Diagnostic/Surgical | FSP | 1 | Contract manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Contract manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2016 | K160097 | Image Fast Set, Image Regular Set | ELW | Substantially Equivalent | Sybron Dental Specialties | accessdata.fda.gov |
| June 30, 2016 | K160441 | Identic and KromaFaze Alginate Dental Impression Materials | ELW | Substantially Equivalent | Kerr Corporation | accessdata.fda.gov |
| April 5, 2011 | K110378 | IMPRESSION COMPOUND | ELW | Substantially Equivalent | Spofadental | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression
- All makers of Point, Abrasive
- All makers of Clamp, Rubber Dam
- All makers of Cord, Retraction
- All makers of Loupe, Diagnostic/Surgical
- All makers of Disk, Abrasive
Updated August 5, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.