Question 1

What types of medical devices does Common Sense Dental Products manufacture?

Accepted Answer

Common Sense Dental Products specializes in dental devices, including suction tools like the LogiBloc+Suction (available in pediatric and standard sizes with left/right variants) and dental wedges (e.g., FlexiWedge in large and extra-large sizes with color-coded refills). They also produce measurement tools called Prep Check gauges, which help clinicians verify dental preparation depths in millimeters for restorative work.

Question 2

Where is Common Sense Dental Products based?

Accepted Answer

The company is headquartered in the United States. While its primary market may be global, its regulatory filings and manufacturing operations are centered there.

Question 3

Which regulatory registries list Common Sense Dental Products’ devices?

Accepted Answer

The company’s devices are listed in the EUDAMED database, which is the European Union’s transparency platform for medical devices. This registry is used to track devices authorized under EU regulations, including those classified as Class I.

Question 4

How are Common Sense Dental Products’ devices classified under EU regulations?

Accepted Answer

All of Common Sense Dental Products’ devices fall under Class I classification in the EU. This classification applies to low-risk devices like dental suction tools, wedges, and measurement gauges, which typically require less stringent regulatory oversight than higher-risk categories.

Device	Model / Reference	Registries	Class	Status
LogiBloc+Suction Pediatric Left	PLBB	EUDAMED	Class I	Active
FlexiWedge Large Purple Refill	FW05	EUDAMED	Class I	Active
Prep Check 1mm Pink	PPC	EUDAMED	Class I	Active
FlexiWedge Extra Large Red Refill	FW01	EUDAMED	Class I	Active
PrepCheck Mini	MGPC	EUDAMED	Class I	Active
LogiBloc+Suction Pediatric Right	PRBB	EUDAMED	Class I	Active
LogiBloc Standard Green	SBB	EUDAMED	Class I	Active
Prep Check Mini	BPCM	EUDAMED	Class I	Active
Prep Check 2mm Blue	BPC	EUDAMED	Class I	Active
LogiBloc+Suction Standard Left	SLBB	EUDAMED	Class I	Active
Prep Check 1.5mm Green	GPC	EUDAMED	Class I	Active
LogiBloc+Suction Standard Right	SRBB	EUDAMED	Class I	Active
LogiBloc Large Blue	LBB	EUDAMED	Class I	Active
LogiBloc Extra Small Yellow	XSBB	EUDAMED	Class I	Active
LogiBloc Pediatric Purple	PBB	EUDAMED	Class I	Active
FlexiWedge Extra Small Blue Refill	FW02	EUDAMED	Class I	Active
FlexiWedge Kit Assorted Sizes	KW100	EUDAMED	Class I	Active
FlexiWedge Small Orange Refill	FW04	EUDAMED	Class I	Active
FlexiWedge Medium Green Refill	FW03	EUDAMED	Class I	Active

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