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PARKELL, INC.

United States·US-MF-000003761

Last updated September 17, 2026

Information

Country
United States
Address
300, Executive Drive, Edgewood, United States
LinkedIn
—
Facebook
—
Phone
6312491134
PRRC Contact
Yasily Ogando
EUDAMED SRN
US-MF-000003761
FDA FEI Number
2411797
DUNS Number
009900424

Catalogue (798)

Page 12 of 16
DeviceModel / ReferenceRegistriesClassStatus
AccuFilm® Red/Black Booklet
FDA UDI
Class IUnknown
Blu-Mousse® S457S
FDA UDI
Class IIActive
SmarTemp® S340
FDA UDI
Class IIUnknown
Gripper™ Soft Copper Band S702-08
FDA UDI
Class IUnknown
Digitest™ D626DGC
FDA UDI
Class IIActive
Parkell® SDS-881-014M
FDA UDI
Class IActive
Amalgambond® S372
FDA UDI
Class IIUnknown
Parkell® SDS-6055-018C
FDA UDI
Class IActive
Parkell® SDS-847-018SC
FDA UDI
Class IActive
Parkell® DORING-GR
FDA UDI
Class IIActive
Absolute Polishers™ S081
FDA UDI
Class IUnknown
Snap™ S443
FDA UDI
Class IIUnknown
Epic® S312
FDA UDI
Class IIUnknown
Parkell® SD863
FDA UDI
Class IUnknown
Brush&Bond® S240
FDA UDI
Class IIUnknown
Absolute Polishers™ S085
FDA UDI
Class IUnknown
C.i.™ S094
FDA UDI
Class IActive
Snap™ S424
FDA UDI
Class IIUnknown
Parkell® SDS-830-012M
FDA UDI
Class IActive
AccuFilm® S015-K
FDA UDI
Class IActive
Brush&Bond® S242
FDA UDI
Class IIUnknown
Touch&Bond® S280
FDA UDI
Class IIUnknown
SmarTemp® S346-A3
FDA UDI
Class IIUnknown
C.i.™ S114
FDA UDI
Class IActive
Epic® S363UD
FDA UDI
Class IIActive
Sensimatic® D700SE110
FDA UDI
Class IIActive
Gripper™ Soft Copper Band S702-17
FDA UDI
Class IUnknown
Parkell® SD703-8
FDA UDI
Class IUnknown
Mach-2® S432S
FDA UDI
Class IIUnknown
Thermique™ D532
FDA UDI
Class IIUnknown
Dryz™ S192SP
FDA UDI
UActive
Dryz™ S185UD
FDA UDI
UUnknown
Epic® S361
FDA UDI
Class IIActive
C.i.™ S104
FDA UDI
Class IUnknown
Parkell® SDS-859-014VF
FDA UDI
Class IActive
Aurora™ D547
FDA UDI
Class IIUnknown
Parkell® SDS-862-014C
FDA UDI
Class IActive
MetaSeal® S160
FDA UDI
Class IIActive
Turbo Piezo™ D690110
FDA UDI
Class IIUnknown
Snap™ S449-K
FDA UDI
Class IIActive
Snap™ S803
FDA UDI
Class IIActive
Snap™ S813
FDA UDI
Class IIActive
Gripper™ Soft Copper Band S702-10
FDA UDI
Class IUnknown
Absolute Dentin™ S299
FDA UDI
Class IIUnknown
PerioSonic® D581
FDA UDI
Class IIUnknown
Ea-Z-y Primer™ S388
FDA UDI
Class IIUnknown
C.i.™ S093
FDA UDI
Class IActive
Snap™ S459
FDA UDI
Class IIUnknown
Snap™ S840
FDA UDI
Class IIActive
Turbo Piezo™ D691
FDA UDI
Class IIActive

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