GoldenDent

Address:27251 Gratiot Ave,Roseville,MI,48066,US

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Filters

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

BUR, DENTAL (EJL) (5) FORCEPS, GENERAL & PLASTIC SURGERY (GEN) (4) INSTRUMENTS, DENTAL HAND (DZN) (1)

Premarket Exempt

No Yes

Clear

GoldenDent - 00850011211113 Catalog Number : FS NTS

Device Description : Needle Holder 7 inch Thumb Lock w round handle straight tip

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211120 Catalog Number : FS NUS

Device Description : Needle Holder 7 inch Universal round handle straight tip

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211137 Catalog Number : RS RFU

Device Description : Resorative Universal Forceps

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211144 Catalog Number : FS SFC

Device Description : Suture Removal Scissors and Forcep combo

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211151 Catalog Number : FS TFU

Device Description : Tunneling Graft Forceps

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211168 Catalog Number : GBSB

Device Description : Bone Shaping Bur Ball

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211175 Catalog Number : GBSO

Device Description : Bone Shaping Bur Oval.

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211182 Catalog Number : GCCB

Device Description : Cutting Bur

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211199 Catalog Number : GDBL

Device Description : Tissue and Degranulation Bur Large

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211205 Catalog Number : GDBM

Device Description : Tissue and Degranulation Bur Medium

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 1

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