FDA.report

Thino Roth Bracket,.022,Mini Size,w/hs at #3

Primary DI
06973329320088
Brand
Thino Roth Bracket,.022,Mini Size,w/hs at #3
Company
Astar Orthodontics Inc.
Model
1212-55-3H
Published
2023-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EJFBracket, Metal, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06973329320088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06973329320088069733293200886973329320088

GMDN Terms

TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
547794613
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
86941673501459Thino Roth Bracket, .022, Mini Size, UL11212-0112023-12-31
86941673501466Thino Roth Bracket, .022, Mini Size, UL21212-0122023-12-31
86941673501473Thino Roth Bracket, .022 Mini, UL3, w/hk at distal1212-013Hd2023-12-31
86941673501480Thino Roth Bracket, .022 Mini, UL4, w/o hook1212-0142023-12-31
86941673501497Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial1212-014Hm2023-12-31
86941673501503Thino Roth Bracket, .022 Mini, UL4, w/hk at distal1212-014Hd2023-12-31
86941673501510Thino Roth Bracket, .022 Mini, UL5, w/o hook1212-0152023-12-31
86941673501527Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial1212-015Hm2023-12-31
86941673501534Thino Roth Bracket, .022 Mini, UL5, w/hk at distal1212-015Hd2023-12-31
86941673501541Thino Roth Bracket, .022, Mini Size, UR11212-0212023-12-31
86941673501558Thino Roth Bracket, .022, Mini Size, UR21212-0222023-12-31
06941673501569Thino Roth Bracket, .022 Mini, UR3, w/hk at distal1212-023Hd2023-12-31
86941673501572Thino Roth Bracket, .022 Mini, UR4, w/o hook1212-0242023-12-31
86941673501589Thino Roth Bracket, .022 Mini, UR4, w/hk at mesial1212-024Hm2023-12-31
86941673501596Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-024Hd2023-12-31
86941673501602Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-0252023-12-31
86941673501619Thino Roth Bracket, .022 Mini, UR5, w/hk at mesial1212-025Hm2023-12-31
86941673501626Thino Roth Bracket, .022 Mini, UR5, w/hk at distal1212-025Hd2023-12-31
86941673501633Thino Roth Bracket, .022, Mini Size, LL11212-0312023-12-31
86941673501640Thino Roth Bracket, .022, Mini Size, LL21212-0322023-12-31

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