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

FORCEPS, GENERAL & PLASTIC SURGERY (GEN) (5) FILE, PULP CANAL, ENDODONTIC (EKS) (3) SCISSORS, GENERAL, SURGICAL (LRW) (2)

Premarket Exempt

No Yes

Clear

GoldenDent - 00850011211014 Catalog Number : FS BFE

Device Description : Broken File Extraction Intro Kit: Included 45, 75, 90 & 100 degree retrieval probes

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211021 Catalog Number : FS EF1

Device Description : Endo File Forcep #1 90 Degree in line access

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211038 Catalog Number : FS EF2

Device Description : Endo File Forcep #2 75 Degree in line access

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211045 Catalog Number : FS FSS

Device Description : Featherlike Suture Scissors

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211052 Catalog Number : FS IA1

Device Description : Healing Abutment Forcep #1 90 Degree

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211069 Catalog Number : FS IA2

Device Description : Healing Abutment Forcep #1 75 Degree

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211076 Catalog Number : FS MTS

Device Description : Micro Periodontal Tissue Scissors

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211083 Catalog Number : FS NCC

Device Description : Needle Holder 6 inch Advanced with Suture cutter and curved tips

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211090 Catalog Number : FS NCS

Device Description : Needle Holder 7 inch Advanced with Round handle with suture cutter and straight tips

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

GoldenDent - 00850011211106 Catalog Number : FS NTC

Device Description : Needle Holder 7 inch Thumb Lock w suture cutter and straight tips

Device Class : 1

Duns Number: 078273228

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

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