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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
Website: www.parkell.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 6312491134
PRRC Contact: Yasily Ogando
EUDAMED SRN: US-MF-000003761
FDA FEI Number: 2411797
DUNS Number: 009900424

Catalogue (798)

Page 16 of 16

Device	Model / Reference	Registries	Class	Status
TurboSENSOR +™	D660-N	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S335	EUDAMEDFDA UDI	Class I	Active
Absolute Dentin®	S301	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S391	EUDAMEDFDA UDI	Class I	Active
AccuFilm I	S014	EUDAMEDFDA UDI	Class I	Active
Cinch®	S454S	EUDAMEDFDA UDI	Class I	Active
Predicta™	S615	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S327	EUDAMEDFDA UDI	Class I	Active
Parkell®	D625	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S535	EUDAMEDFDA UDI	Class I	Active
Parkell®	S622	EUDAMEDFDA UDI	Class I	Active
Digitest™	D655	EUDAMEDFDA UDI	Class IIa	Active
AccuFilm II	S018	EUDAMEDFDA UDI	Class I	Active
Predicta™	S605	EUDAMEDFDA UDI	Class IIa	Active
DryZ®	S180	EUDAMEDFDA UDI	Class I	Active
TurboSENSOR +™	D660-O	EUDAMEDFDA UDI	Class IIa	Active
Hyperfil®	S234	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S181	EUDAMEDFDA UDI	Class I	Active
DuraTip®	DURA30-US	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	DPI25	EUDAMEDFDA UDI	Class IIa	Active
Cinch®	S463S	EUDAMEDFDA UDI	Class I	Active
GentleCLEAN™	DSG30GCT	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	DPR30	EUDAMEDFDA UDI	Class IIa	Active
Cinch®	S453S	EUDAMEDFDA UDI	Class I	Active
Burnett Power-Tip™	DSG30T	EUDAMEDFDA UDI	Class IIa	Active
DuraTip®	DURA30-PS	EUDAMEDFDA UDI	Class IIa	Active
TurboVUE™	D572	EUDAMEDFDA UDI	Class I	Active
DryZ®	S191	EUDAMEDFDA UDI	Class I	Active
TurboSENSOR®	D560-230	EUDAMEDFDA UDI	Class IIa	Active
DryZ®	S187	EUDAMEDFDA UDI	Class I	Active
Parkell®	DSG30R	EUDAMEDFDA UDI	Class IIa	Active
Predicta™	S630	EUDAMEDFDA UDI	Class IIa	Active
DryZ®	S183	EUDAMEDFDA UDI	Class I	Active
DuraTip®	DURA30-PSR	EUDAMEDFDA UDI	Class IIa	Active
Cinch®	S464	EUDAMEDFDA UDI	Class I	Active
Predicta™	S611	EUDAMEDFDA UDI	Class IIa	Active
PureClarity™	D718	EUDAMEDFDA UDI	Class I	Active
Green-Mousse®	S455S	EUDAMEDFDA UDI	Class I	Active
Blu-Mousse®	S448S	EUDAMEDFDA UDI	Class I	Active
Burnett Power-Tip™	DTI25	EUDAMEDFDA UDI	Class IIa	Active
Simplee®	156215	EUDAMEDFDA UDI	Class I	Active
Parkell®	D631GC	EUDAMEDFDA UDI	Class IIa	Active
TurboSENSOR +™	D660-P	EUDAMEDFDA UDI	Class IIa	Active
Predicta™	S606	EUDAMEDFDA UDI	Class IIa	Active
Hedgehog™	S497	EUDAMEDFDA UDI	Class I	Active
Absolute Dentin®	S304	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S496	EUDAMEDFDA UDI	Class I	Active
AccuFilm I	S015	EUDAMEDFDA UDI	Class I	Active

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