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) (2) Dentures, Full (NSL) (1) Prosthesis, Orthodontic (NSR) (1) Restoration, Base Metal (NSQ) (1) Restoration, Noble Metal (NSJ) (1) Restoration, Porcelain (NSP) (1) Restoration, Porcelain-Fused-To-Metal (NSO) (1) Accessories, Implant, Dental, Endosseous (NDP) (1) Restoration, Resin, Crown And Bridge (NSN) (1)

Premarket Exempt

No Yes

Clear

The Moses TM Appliance - 06972677870023 Catalog Number :

Device Description : The Moses appliance is intended for use on adult patients 18 years of age and ol The Moses appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and /or alleviation of snoring and mild to moderate obstrctive sleep apnea.

Device Class : 2

Duns Number: 551746187

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Elastic Mandibular Advancement (EMA) appliance - 06972677870030 Catalog Number :

Device Description : The Elastic Mandibular Advancement appliance is a modified fuctional prthodontic The Elastic Mandibular Advancement appliance is a modified fuctional prthodontic appliance. The modifications are:1) clasps are not needed as the appliance is retained firmly to the teeth by pressure formed plastic into the undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened as in the SNOAR and NAPA appliances but not in one fixed position. Multiple bite openings are possible because of removable bite blocks or bite planes of varying thickness. 3) the mandible is advanced as in both the SNOAR and NAPA appliances except not in fixed position, but in various amounts of forward advancement because of removable, replaceable elastic bands or straps to pull the mandible forward.

Device Class : 2

Duns Number: 551746187

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

Restoration - 06972677870047 Catalog Number :

Device Description : Porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and br Porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys.

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSO

Prescription Use : Yes

Device Count : 1

Restoration - 06972677870054 Catalog Number :

Device Description : Porcelain restorations are full porcelain crown and bridge restorations that are Porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSP

Prescription Use : Yes

Device Count : 1

Denture - 06972677870061 Catalog Number :

Device Description : Full dentures are manufactured as finished products from denture resins.

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSL

Prescription Use : Yes

Device Count : 1

Orthodontic - 06972677870078 Catalog Number :

Device Description : Orthodontic prosthesis are finished custom-fit orthodontic prosthesis,such as Mo Orthodontic prosthesis are finished custom-fit orthodontic prosthesis,such as Mouthguard; Nightguard; Orthodontic Appliance; Screw Appliance.

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSR

Prescription Use : Yes

Device Count : 1

Restoration - 06972677870085 Catalog Number :

Device Description : Noble metal restorations are crowns, bridges, inlays, and onlays that are manufa Noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals.

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSJ

Prescription Use : Yes

Device Count : 1

Restoration - 06972677870092 Catalog Number :

Device Description : Resin crown and bridge restorations are crown and bridge restorations that are m Resin crown and bridge restorations are crown and bridge restorations that are manufactured as finished products from resins.

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSN

Prescription Use : Yes

Device Count : 1

Surgical Guide - 06972677870108 Catalog Number :

Device Description : Endosseous dental implant accessories.

Device Class : 1

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Restoration - 06972677870115 Catalog Number :

Device Description : Base metal restorations are crowns, bridges, inlays, and onlays that are manufa Base metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from base metals.

Device Class :

Duns Number: 551746187

Premarket Exempt : Yes

Product Code : NSQ

Prescription Use : Yes

Device Count : 1

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