FDA.reportPublic FDA data

NA

Primary DI
00817573024322
Brand
NA
Company
LANCER ORTHODONTICS, INC.
Model
837-131
Device description
WEDGE NECK PAD W/MODULE
Published
2017-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZBHeadgear, Extraoral, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901958000GUARDIAN SAFE BOWLancer Orthodontics, Inc.1990-07-30DZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817573024322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817573024322008175730243228175730243220817573024322

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
045545589
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817573022816NA551-4022017-01-12
00817573022823NA551-402RM2017-01-12
00817573022830NA551-4032017-01-12
00817573022847NA551-403RM2017-01-12
00817573022878NA551-7352017-01-12
00817573022885NA551-9252017-01-12
00817573024551NASAMS122017-01-15
00817573022892NA810-2112017-01-12
00817573022977NA810-5022017-01-12
00817573022984NA810-5032017-01-12
00817573022991NA810-5102017-01-12
00817573023004NA810-5222017-01-12
00817573023011NA810-5232017-01-12
00817573023028NA810-5242017-01-12
00817573023035NA810-5252017-01-12
00817573023042NA810-5262017-01-12
00817573023059NA810-5272017-01-12
00817573023066NA810-5282017-01-12
00817573023073NA810-5292017-01-12
00817573023189Rely-a-Bond811-0022017-01-12

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Primary DI, Brand, Company table
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