FDA.reportPublic FDA data

Plastic Conditioner

Primary DI
00190730004512
Brand
Plastic Conditioner
Company
ORTHO TECHNOLOGY, INC.
Model
OT-PL
Device description
Plastic Conditioner 15ml per bottle
Published
2016-09-24
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
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921044000ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BONDWallace A. Erickson & Co.1992-11-09DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190730004512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190730004512001907300045121907300045120190730004512

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
781772017
Device count
1
DM 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
00190730000088Resilience5010092016-09-24
00190730000095Resilience5032042016-09-24
00190730000101Resilience5061012016-09-24
00190730000118Resilience5061022016-09-24
00190730000125Resilience5061042016-09-24
00190730000132Resilience5061062016-09-24
00190730000149Resilience5061072016-09-24
00190730084538Clear Advantage7500-1002025-07-24
00190730084545Clear Advantage7500-1052025-07-24
00190730084552Clear Advantage7500-1102025-07-24
00190730084569Clear Advantage7500-0352025-07-24
00190730084576Clear Advantage7500-0402025-07-24
00190730084583Sports Advantage7500-1652025-07-24
00190730084590Sports Advantage7500-1402025-07-24
10190730084535Clear Advantage7500-1002025-07-24
10190730084542Clear Advantage7500-1052025-07-24
10190730084559Clear Advantage7500-1102025-07-24
10190730084566Clear Advantage7500-0352025-07-24
10190730084573Clear Advantage7500-0402025-07-24
10190730084580Sports Advantage7500-1652025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998073557SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073564SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073571SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998062407SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062551SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062988SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998062995SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063008SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063015SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063169SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063176SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063183SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063190SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063206SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063213SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063244SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063251SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063268SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063275SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063299SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063305SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063312SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063329SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063947SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063954SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063961SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063978SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063985SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998063992SolventumSolventum Orthodontics CorporationDYH2026-10-24
00197998064005SolventumSolventum Orthodontics CorporationDYH2026-10-24