FDA.report

Reverse Pull Headgear(Face Mask), Middle, Green

Primary DI
06973329326103
Brand
Reverse Pull Headgear(Face Mask), Middle, Green
Company
Astar Orthodontics Inc.
Model
5268-5006
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
false

Related Records

Product Codes

CodeName
KCRFacebow

Product Code Classifications

CodeDeviceSpecialtyClass
KCRFacebowDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06973329326103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06973329326103069733293261036973329326103

GMDN Terms

TermDefinition
Orthodontic extraoral headgearA dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).

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

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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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