FDA.reportPublic FDA data

Reverse Pull Headgear(Face Mask), Middle, Yellow

Primary DI
06973329326073
Brand
Reverse Pull Headgear(Face Mask), Middle, Yellow
Company
Astar Orthodontics Inc.
Model
5268-5003
Published
2023-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCRFacebow

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCRFacebowDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973329326073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973329326073069733293260736973329326073

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
547794613
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941673501453Thino Roth Bracket, .022, Mini Size, UL11212-0112023-12-31
06941673501460Thino Roth Bracket, .022, Mini Size, UL21212-0122023-12-31
06941673501477Thino Roth Bracket, .022 Mini, UL3, w/hk at distal1212-013Hd2023-12-31
06941673501484Thino Roth Bracket, .022 Mini, UL4, w/o hook1212-0142023-12-31
06941673501491Thino Roth Bracket, .022 Mini, UL4, w/hk at mesial1212-014Hm2023-12-31
06941673501507Thino Roth Bracket, .022 Mini, UL4, w/hk at distal1212-014Hd2023-12-31
06941673501514Thino Roth Bracket, .022 Mini, UL5, w/o hook1212-0152023-12-31
06941673501521Thino Roth Bracket, .022 Mini, UL5, w/hk at mesial1212-015Hm2023-12-31
06941673501538Thino Roth Bracket, .022 Mini, UL5, w/hk at distal1212-015Hd2023-12-31
06941673501545Thino Roth Bracket, .022, Mini Size, UR11212-0212023-12-31
06941673501552Thino Roth Bracket, .022, Mini Size, UR21212-0222023-12-31
06941673501576Thino Roth Bracket, .022 Mini, UR4, w/o hook1212-0242023-12-31
06941673501583Thino Roth Bracket, .022 Mini, UR4, w/hk at mesial1212-024Hm2023-12-31
06941673501590Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-024Hd2023-12-31
06941673501606Thino Roth Bracket, .022 Mini, UR4, w/hk at distal1212-0252023-12-31
06941673501613Thino Roth Bracket, .022 Mini, UR5, w/hk at mesial1212-025Hm2023-12-31
06941673501620Thino Roth Bracket, .022 Mini, UR5, w/hk at distal1212-025Hd2023-12-31
06941673501637Thino Roth Bracket, .022, Mini Size, LL11212-0312023-12-31
06941673501644Thino Roth Bracket, .022, Mini Size, LL21212-0322023-12-31
06941673501651Thino Roth Bracket, .022 Mini, LL3, w/hk at distal1212-033Hd2023-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040022720#2240Q ART/#8645 FACE BOW IN BOXWHIP-MIX CORPORATIONKCR2025-09-11
07615208459579UTS 3D/ UTS CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKCR2024-06-26
07615208460483UTS 3D/ UTS CADIVOCLAR VIVADENT AKTIENGESELLSCHAFTKCR2024-06-26
06973329326059Reverse Pull Headgear(Face Mask), Middle, RedAstar Orthodontics Inc.KCR2023-12-31
06973329326066Reverse Pull Headgear(Face Mask), Middle, BlueAstar Orthodontics Inc.KCR2023-12-31
06973329326080Reverse Pull Headgear(Face Mask), Middle, OrangeAstar Orthodontics Inc.KCR2023-12-31
06973329326097Reverse Pull Headgear(Face Mask), Middle, PurpleAstar Orthodontics Inc.KCR2023-12-31
06973329326103Reverse Pull Headgear(Face Mask), Middle, GreenAstar Orthodontics Inc.KCR2023-12-31
G586E8310210Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310220Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310310Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310320Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
G586E8310330Novo SurgicalNOVO SURGICAL, INC.KCR2023-12-18
E1996625211CRS Set 15Candulor AGKCR2023-11-16
E1996624511Bite forkCandulor AGKCR2023-11-16
E1996624531Bite fork SetCandulor AGKCR2023-11-16
E1996625131CRS Set 10Candulor AGKCR2023-11-16
D04020002950Unit-Assy SlidematicWHIP-MIX CORPORATIONKCR2023-10-27
D04020011540Unit Assembly 9645 FBWHIP-MIX CORPORATIONKCR2023-10-27
00850211006144Facial Plane RelatorHO DENTAL COMPANY LLCKCR2023-05-17
00842331179730Novo Surgical Inc. NOVO SURGICAL, INC.KCR2022-11-14
E4942186801accessoryAmann Girrbach AGKCR2022-09-08
E4942186901accessoryAmann Girrbach AGKCR2022-09-08
E4942176951accessoryAmann Girrbach AGKCR2022-09-07
E4942186071accessoryAmann Girrbach AGKCR2022-09-07
E4942186351accessoryAmann Girrbach AGKCR2022-09-07
E4942176112accessoryAmann Girrbach AGKCR2022-08-22
E4942176611accessoryAmann Girrbach AGKCR2022-08-22
E4942179285accessoryAmann Girrbach AGKCR2022-08-22
E4942186001ArtexAmann Girrbach AGKCR2022-08-22