Question 1

What types of medical devices does Guilin Woodpecker Medical Instrument Co., Ltd. manufacture?

Accepted Answer

Guilin Woodpecker Medical Instrument Co., Ltd. specializes in dental devices, primarily ultrasonic handpieces and tips used for scaling, debridement, and periodontal treatment. Their portfolio includes systems for endodontic and surgical applications, as well as remotely-driven dental power tools and polymerization lamps for curing dental materials. These devices are engineered for precision in procedures like cleaning teeth, cutting tissue, and hardening restorative materials.

Question 2

Where is Guilin Woodpecker Medical Instrument Co., Ltd. based?

Accepted Answer

The company is headquartered in China, as indicated by its country of origin. This location reflects its operational and manufacturing base for the devices it produces.

Question 3

Which regulatory registries or databases list Guilin Woodpecker Medical Instrument Co., Ltd.’s devices?

Accepted Answer

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This inclusion means their products comply with U.S. regulatory requirements for identification and traceability, though it does not imply approval or clearance for individual devices.

Question 4

How are Guilin Woodpecker Medical Instrument Co., Ltd.’s devices classified under regulatory frameworks?

Accepted Answer

The devices manufactured by Guilin Woodpecker Medical Instrument Co., Ltd. fall into three regulatory classifications: Class I, Class II, and Unclassified (U). The classification depends on factors like risk level, intended use, and potential impact on patient safety, with Class I generally representing lower-risk devices and Class II higher-risk ones requiring additional scrutiny.

Device	Model / Reference	Registries	Class	Status
Cordless Prophy System, Model: i-Polish	K211531	FDA 510(k)	Class I	Active
Dental Air Polishing Handpiece	K221548	FDA 510(k)	Class I	Active
Imaging Plate Scanner, i-Scan	K212080	FDA 510(k)	Class II	Active
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )	K251438	FDA 510(k)	Class II	Active
Led.l, Led.m, Led.g, Led.b	K080025	FDA 510(k)	Class II	Active
D-Laser Blue, D-Laser 16	K210367	FDA 510(k)	Class II	Active
MotoPex	MotoPex0150	EUDAMEDFDA UDI	Class IIa	Active
Yz-2l(bac5l)	BA150160	EUDAMED	Class IIa	Active
CA361-H(GenENDO Contra-angle)	Z1211	EUDAMED	Class IIa	Active
Endo Motor	EndoPace0249	EUDAMED	Class IIa	Active
Dpex V	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Curing Light	Z1211	EUDAMED	Class I	Active
Fi-G	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Dental Electric Motor	MT3	EUDAMEDFDA UDI	Class IIa	Active
Dental Diode Laser Device	LX160187、LX16Plus0188	EUDAMED	Class IIb	Active
Woodpex III	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Dpex I	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Woodpex I	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Dpex X	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Endo Radar	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Dpex III	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Pt-B	Z121101	EUDAMEDFDA UDI	Class IIa	Active
Uds-T Led (ba300100)	BAC300E	EUDAMED	Class IIa	Active
Endo Smart Pro	Z1211	EUDAMED	Class IIa	Active
Uds-T Led (ba300250)	BAC300SL	EUDAMED	Class IIa	Active
812 Mt	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Endo Radar Plus	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Rooter X4000	Z1211	EUDAMED	Class IIa	Active
Fi-E (EDGEFLOW)	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Woodpex X	Z1211	EUDAMED	Class IIa	Active
Endo Free(GenENDO Motor)	Z1211	EUDAMED	Class IIa	Active
Ai-Motor (EDGEAPEX HP)	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Gutta Percha Obturation Device	FiP0184	EUDAMEDFDA UDI	Class IIa	Active
Pt-E	Z121101	EUDAMED	Class IIa	Active
Pt-A	Z121101	EUDAMEDFDA UDI	Class IIa	Active
Ai-Motor	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Woodpex V	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Ca361-H(ba361-H)	Z1211	EUDAMED	Class IIa	Active
Endo Pace(BAE360R)	BA182360	EUDAMED	Class IIa	Active
Uds-T Led (ba300150)	BAC300EL	EUDAMED	Class IIa	Active
Ultrasonic Scalers	UDSN60198、V60199	EUDAMED	Class IIa	Active
Ap-2(bac5b)	BA150155	EUDAMED	Class IIa	Active
Ca161(ba182611)	Z1211	EUDAMED	Class IIa	Active
Ulticlean Uc600l	BA260100	EUDAMED	Class IIa	Active
Fi-G(BAE340)	BA182800	EUDAMED	Class IIa	Active
Fi-P (EDGEPACK)	Z1211	EUDAMEDFDA UDI	Class IIa	Active
Dental Scaler and Air Polisherh	APB0256	EUDAMEDFDA UDI	Class IIa	Active
D600 Led	D600LED0052	EUDAMEDFDA UDI	Class IIa	Active
BAE380R (Ai Motor)	BAE380R195	EUDAMED	Class IIa	Active
Endo 3(BAE320)	BA182100	EUDAMED	Class IIa	Active

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