JOHN'S DENTAL LABORATORY INC

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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

Abutment, Implant, Dental, Endosseous (NHA) (1) Additively Manufactured, Preformed, Resin Denture Tooth (PZY) (1) Aligner, Sequential (NXC) (1) Device, Anti-Snoring (LRK) (1) Device, Jaw Repositioning (LQZ) (1) Mouthguard, Migraine/Tension Headache (OCO) (1) Resin, Denture, Relining, Repairing, Rebasing (EBI) (1)

Premarket Exempt

Yes No

Clear

Abutment/Implant - 00810002220104 Catalog Number :

Device Description : To be used in conjunction with an endosseous dental implant fixture to aid in pr To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Device Class : 2

Duns Number: 016649253

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

mmRNA appliance - 00810002220111 Catalog Number :

Device Description : The mmRNA appliance is an intraoral device used for treating snoring and mild to The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. Itconsists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep.

Device Class : 2

Duns Number: 016649253

Premarket Exempt : No

Product Code : LRK, LQZ

Prescription Use : No

Device Count : 1

Digital Denture - 00810002220128 Catalog Number :

Device Description : Digital patient scan is used in conjunction with software and a 3D printer to bu Digital patient scan is used in conjunction with software and a 3D printer to build patient-matched denture teeth by depositing layer upon layer of the resin material. Denture relining, repairing, or rebasing resin.

Device Class : 2

Duns Number: 016649253

Premarket Exempt : No

Product Code : PZY, EBI

Prescription Use : No

Device Count : 1

Redline - 00810002220135 Catalog Number :

Device Description : Orthodontic plastic bracket. The device moves the teeth by continuous gentle for Orthodontic plastic bracket. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion. A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.

Device Class : 2

Duns Number: 016649253

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Vivos DNA-Lower - 00810002220159 Catalog Number :

Device Description : Lower mouth guard, migraine/tension headache, Jaw repositioning device

Device Class : U

Duns Number: 016649253

Premarket Exempt : No

Product Code : OCO

Prescription Use : No

Device Count : 1

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