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) (9) Crown And Bridge, Temporary, Resin (EBG) (1)

Premarket Exempt

No Yes

Clear

UltraPrint-Dental Denture Teeth UV - 06971437940150 Catalog Number :

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

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940167 Catalog Number :

Device Description : 1000g, 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 - 06971437940174 Catalog Number :

Device Description : 1000g, UltraPrint-Dental Denture Teeth UV-A2

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940181 Catalog Number :

Device Description : 1000g, UltraPrint-Dental Denture Teeth UV-Bleach

Device Class : 2

Duns Number: 418561545

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

UltraPrint-Dental Denture Teeth UV - 06971437940198 Catalog Number :

Device Description : 1000g, 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 - 06971437940204 Catalog Number :

Device Description : 1000g, 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 - 06971437940211 Catalog Number :

Device Description : 1000g, 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 - 06971437940228 Catalog Number :

Device Description : 1000g, 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 - 06971437940235 Catalog Number :

Device Description : 1000g, 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 - 06971437940242 Catalog Number :

Device Description : UltraPrint-Dental Temp C&B UV, 250g/bottle, A3.5

Device Class : 2

Duns Number: 418561545

Premarket Exempt : No

Product Code : EBG

Prescription Use : Yes

Device Count : 1

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