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Sign in to claim this brandPARKELL, INC.
United States·US-MF-000003761
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 300, Executive Drive, Edgewood, United States
- Website
- www.parkell.com
- —
- —
- [email protected]
- Phone
- 6312491134
- PRRC Contact
- Yasily Ogando
- EUDAMED SRN
- US-MF-000003761
- FDA FEI Number
- 2411797
- DUNS Number
- 009900424
Catalogue (798)
Page 13 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gripper™ Soft Copper Band | S702-18 | FDA UDI | Class I | Unknown |
| Snap™ | S424 | FDA UDI | Class II | Active |
| Absolute Polishers™ | S080 | FDA UDI | Class I | Unknown |
| Mach-SLO™ | S430S | FDA UDI | Class I | Unknown |
| Expandex™ | S226 | FDA UDI | Class I | Unknown |
| Absolute Dentin™ | S307-K | FDA UDI | Class II | Active |
| Gripper™ Soft Copper Band | S702-02 | FDA UDI | Class I | Unknown |
| Aurora™ | D542110 | FDA UDI | Class II | Unknown |
| MucoSoft® | S494 | FDA UDI | Class II | Active |
| C.i.™ | S107 | FDA UDI | Class I | Unknown |
| Sharp™ | S511 | FDA UDI | Class II | Unknown |
| TurboSENSOR® | D576 | EUDAMEDFDA UDI | Class I | Active |
| Hedgehog™ | S502 | EUDAMEDFDA UDI | Class I | Active |
| DryZ® | S190 | EUDAMEDFDA UDI | Class I | Active |
| DuraTip® | DURA30-PSL | EUDAMEDFDA UDI | Class IIa | Active |
| TurboSENSOR +™ | D660-B | EUDAMEDFDA UDI | Class IIa | Active |
| Predicta™ | S600 | EUDAMEDFDA UDI | Class IIa | Active |
| Blu-Mousse® | S438S | EUDAMEDFDA UDI | Class I | Active |
| Cinch® | S461S | EUDAMEDFDA UDI | Class I | Active |
| Blu-Mousse® | S437S | EUDAMEDFDA UDI | Class I | Active |
| AccuFilm II | S053 | EUDAMEDFDA UDI | Class I | Active |
| Totalbond | K990381 | FDA 510(k) | Class II | Active |
| Easy Bond | K972421 | FDA 510(k) | Class II | Active |
| Turbo 25/30 | K950256 | FDA 510(k) | Class II | Active |
| Aeroetcher | K973679 | FDA 510(k) | Class II | Active |
| Celerity | K062518 | FDA 510(k) | Class II | Active |
| Brush&Bond Plus | K151518 | FDA 510(k) | Class II | Active |
| Abrakadabra - Dental Adhesive System | K892003 | FDA 510(k) | Class II | Active |
| Ms Emulsion | K952123 | FDA 510(k) | Class II | Active |
| Parkell Self-Adhesive Cement | K210259 | FDA 510(k) | Class II | Active |
| Silagum | K792363 | FDA 510(k) | Class II | Active |
| Foramatron Iv | K950857 | FDA 510(k) | U | Active |
| Sensimatic 500se | K950239 | FDA 510(k) | Class II | Active |
| Abond | K952124 | FDA 510(k) | Class II | Active |
| C & B Metabond (modification) | K960464 | FDA 510(k) | Class II | Active |
| Epic-Flo | K973976 | FDA 510(k) | Class II | Active |
| Caries Stain | K973200 | FDA 510(k) | Class II | Active |
| Aurora | K063003 | FDA 510(k) | Class II | Active |
| Gental Pulse | K950238 | FDA 510(k) | Class II | Active |
| Le Clean Machine | K950240 | FDA 510(k) | Class II | Active |
| Smartemp | K991270 | FDA 510(k) | Class II | Active |
| D/C Core Material | K010475 | FDA 510(k) | Class II | Active |
| Resin Tooth Bonding Agent | K994302 | FDA 510(k) | Class II | Active |
| V-Primer | K942017 | FDA 510(k) | Class II | Active |
| Cz-S2000 | K060946 | FDA 510(k) | Class II | Active |
| Hybrid Resin Composite | K964867 | FDA 510(k) | Class II | Active |
| Retrieve Implant Cement | K101044 | FDA 510(k) | Class II | Active |
| Touch&Bond-Plus | K020239 | FDA 510(k) | Class II | Active |
| Parkell Universal Adhesive | K172176 | FDA 510(k) | Class II | Active |
| Eazy Primer | K142848 | FDA 510(k) | Class II | Active |
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- Directa AB SE
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