FDA.reportPublic FDA data

Adhere™ Enamel Etch Conditioner

Primary DI
00842452100538
Brand
Adhere™ Enamel Etch Conditioner
Company
ORTHO SPECIALTIES
Model
600-373
Catalog number
600-373
Device description
Phosphoric Acid Etch For Direct Bonding Orthodontic Brackets
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012673000PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEMPrime Dental Manufacturing, Inc.2001-10-24DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842452100538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842452100538008424521005388424521005380842452100538

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit75 Degrees Fahrenheit

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
Expiration 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
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
00842452100637Flames Class III Adjustable Facemask600-527600-5272016-09-24
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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Primary DI, Brand, Company table
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