Modern Dental Laboratory (DG) Co., Ltd.

Address:Room 102 & 1102 & Floor 4-10, Block 1, Modern Dental Industrial Park, No. 7, Nantou Road,,Dongguan Guangdong,CN

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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

Device, Anti-Snoring (LRK) (5) Dentures, Full (NSL) (2) Dentures, Partial (NSK) (2) Aligner, Sequential (NXC) (1) Maintainer, Space Preformed, Orthodontic (DYT) (1) Restoration, Porcelain (NSP) (1)

Premarket Exempt

No Yes

Clear

Denture - 06972677870122 Catalog Number :

Device Description : Partial dentures are manufactured as finished products from denture resins and o Partial dentures are manufactured as finished products from denture resins and other supporting materials.

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSK

Prescription Use : Yes

Device Count : 1

TRIOCLEAR System - 06972677870139 Catalog Number :

Device Description : The TRIOCLEAR System is a removable, non-sterile device intended for single pati The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.

Device Class : 2

Duns Number: 551746187

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Orthodontic retainer - 06972677870146 Catalog Number :

Device Description : An orthodontic appliance, bonded or removable, intended to be used on a single p An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Device Class : 1

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : DYT

Prescription Use : No

Device Count : 1

Blue Series - 06972677870153 Catalog Number :

Device Class : 2

Duns Number: 551746187

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

Pink Series - 06972677870160 Catalog Number :

Device Class : 2

Duns Number: 551746187

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

Blue EF Series - 06972677870177 Catalog Number :

Device Class : 2

Duns Number: 551746187

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

Pink EF Series - 06972677870184 Catalog Number :

Device Class : 2

Duns Number: 551746187

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

Respire Pink AT Series - 06972677870191 Catalog Number :

Device Class : 2

Duns Number: 551746187

Premarket Exempt : No

Product Code : LRK

Prescription Use : No

Device Count : 1

Denture - 06972677871006 Catalog Number :

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSK, NSL

Prescription Use : Yes

Device Count : 2

Restoration - 06972677871020 Catalog Number :

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSL, NSP

Prescription Use : Yes

Device Count : 2

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