FDA.reportPublic FDA data

Flames Class III Adjustable Facemask

Primary DI
00842452100637
Brand
Flames Class III Adjustable Facemask
Company
ORTHO SPECIALTIES
Model
600-527
Catalog number
600-527
Device description
Adjustable Reverse Pull Headgear With Center Bar For Class III Treatment
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K000358000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000358000MULTI ADJUSTABLE FACE MASKOrtho Technology2000-06-09DZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842452100637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842452100637008424521006378424521006370842452100637

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

Contacts#

Phone, Email table
PhoneEmail
800-637-1237contactus@orthospecialties.com

Regulatory Flags#

DUNS number
011050583
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842452100491Adhere™ Light Cure Adhesive 5g Syringe600-369600-3692016-09-24
00842452100507Adhere™ Light Cure Adhesive Kit600-370600-3702016-09-24
00842452100514Adhere™ Light Cure Adhesive Tips600-371600-3712016-09-24
00842452100521Adhere™ Light Cure Adhesive Primer600-372600-3722016-09-24
00842452100538Adhere™ Enamel Etch Conditioner600-373600-3732016-09-24
00842452100545Adhere™ Self Cure Adhesive Kit600-385600-3852016-09-24
00842452100552Adhere™ Self Cure Adhesive Tips600-386600-3862016-09-24
00842452100569Adhere™ Self Cure Activator600-387600-3872016-09-24
00842452100576Adhere™ Self Cure Adhesive 5g Syringe600-388600-3882016-09-24
00842452100583LockTight™ Auto Mix Band Cement Blue600-400600-4002016-09-24
00842452100590Locktight™ Auto Mix Band Cement Natural600-401600-4012016-09-24
00842452100606Multi-Adjustable Facemask600-524600-5242016-09-24
00842452100613American Flag Class III Adjustable Facemask600-525600-5252016-09-24
00842452100620Hawaiian Print Class III Adjustable Facemask600-526600-5262016-09-24
00842452100644Leopard Print Class III Adjustable Facemask600-528600-5282016-09-24
00842452100651Safety Release Modules Light600-557600-5572016-09-24
00842452100668Saftey Release Modules Medium600-558600-5582016-09-24
00842452100675Safety Release Modules Heavy600-559600-5592016-09-24
00842452100705Allgilloid Plus™ Chromatic Cherry Alginate600-643C600-643C2016-09-24
00842452100712Allgilloid Plus™ Chromatic Mint Alginate600-643M600-643M2016-09-24

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