GUANGZHOU HEYGEARS IMC.INC

Address:Room 201-1, No.25, Yayingshi Road, Huangpu District,Guangzhou Guangdong,CN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Additively Manufactured, Preformed, Resin Denture Tooth (PZY) (7) Crown And Bridge, Temporary, Resin (EBG) (3)

Premarket Exempt

No Yes

Clear

UltraPrint-Dental Temp C&B UV - 06971437940044 Catalog Number :

Device Description : UltraPrint-Dental Temp C&B UV, 250g/bottle, A1

Device Class : 2

Duns Number: 418561545

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Temp C&B UV - 06971437940068 Catalog Number :

Device Description : UltraPrint-Dental Temp C&B UV, 250g/bottle, A2

Device Class : 2

Duns Number: 418561545

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940075 Catalog Number :

Device Description : 500g, UltraPrint-Dental Denture Teeth UV-A3

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940082 Catalog Number :

Device Description : 500g, UltraPrint-Dental Denture Teeth UV-A3.5

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940099 Catalog Number :

Device Description : 500g, UltraPrint-Dental Denture Teeth UV-B1

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940105 Catalog Number :

Device Description : 500g, UltraPrint-Dental Denture Teeth UV-B2

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940112 Catalog Number :

Device Description : 500g, UltraPrint-Dental Denture Teeth UV-B3

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Temp C&B UV - 06971437940129 Catalog Number :

Device Description : UltraPrint-Dental Temp C&B UV, 250g/bottle, A3

Device Class : 2

Duns Number: 418561545

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940136 Catalog Number :

Device Description : 500g, UltraPrint-Dental Denture Teeth UV-A1

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940143 Catalog Number :

Device Description : 500g, UltraPrint-Dental Denture Teeth UV-A2

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

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