FDA.reportPublic FDA data

Premier Total Etch

Primary DI
00348783000849
Brand
Premier Total Etch
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
3001422
Device description
PREMIER TOTAL ETCH GEL 12gm
Published
2016-09-21
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
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131212000PREMIER CERAMIC PRIMERPremier Dental Products Co.2013-08-26KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783000849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783000849003487830008493487830008490348783000849

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
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
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10
00348783015607Bond-PR30052552026-06-10
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00348783015614Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00850194007763Zr-P BottleVista DentalKLE2026-06-04
08809518342105Hi-Bond UniversalMEDICLUS CO.,LTDKLE2026-06-01
00197998024269Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024276Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
D0019064140LucitoneDentsply International Inc.KLE2025-07-01
D0019064150LucitoneDentsply International Inc.KLE2025-07-01
D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
07615208298536Monobond PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2024-01-24
D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14
07615208293128Adhese 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208295375Monobond Etch & PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296136Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06