Redline - Orthodontic plastic bracket. The device moves the - JOHN'S DENTAL LABORATORY INC

Duns Number:016649253

Device Description: Orthodontic plastic bracket. The device moves the teeth by continuous gentle force for tre 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.

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More Product Details

Catalog Number

-

Brand Name

Redline

Version/Model Number

3014680794

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K213297

Product Code Details

Product Code

NXC

Product Code Name

Aligner, Sequential

Device Record Status

Public Device Record Key

91eb67ce-b632-414e-ad1f-c4fce549f554

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JOHN'S DENTAL LABORATORY INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 7
U Unclassified 2