FDA.reportPublic FDA data

BITE WING LOOPS

Primary DI
D89260705533440
Brand
BITE WING LOOPS
Company
MAXILL, INC.
Model
6070553344
Published
2022-07-22
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

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D89260705533441PrimaryHIBCC0
D89260705533440Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, single-useA device designed to stabilize a dental x-ray film intraorally during the taking of a dental x-ray. It is typically an adhesive-backed device designed to fold into a T-shape which adheres to the x-ray film and provides a tab that, when bitten down on, stabilizes the film adjacent to the teeth whilst the x-ray is being taken. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079343581
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D89260705601802PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601802024-01-12
D89260705601812PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601812024-01-12
D89260705601822PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601822024-01-12
D89260705601832PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601832024-01-12
D89260705601842PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601842024-01-12
D89260705601852PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601852024-01-12
D89260705601862PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601862024-01-12
D89260705601872PACKARD HEALTHCARE SELF SEALING STERILIZATION POUCHES60705601872024-01-12
D8926070553277D11maxill Frames Eyewear Adult6070553277D12022-11-15
D89260705532601maxill Frames Eyewear60705532602022-11-14
D89260705532631maxill Frames Eyewear60705532632022-11-14
D8926070553265D21maxill Frames Eyewear Kids6070553265D22022-11-14
D8926070553265D31maxill Frames Eyewear Kids6070553265D32022-11-14
D8926070553275C01maxill Frames Eyewear Adult6070553275C02022-11-14
D8926070553275C11maxill Frames Eyewear Adult6070553275C12022-11-14
D8926070553275C21maxill Frames Eyewear Adult6070553275C22022-11-14
D8926070553275C31maxill Frames Eyewear Adult6070553275C32022-11-14
D8926070553275C91maxill Frames Eyewear Adult6070553275C92022-11-14
D8926070553276C01maxill Frames Eyewear Adult6070553276C02022-11-14
D8926070553276C11maxill Frames Eyewear Adult6070553276C12022-11-14

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00810126506528Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
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00810126506559Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506573Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
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