FDA.reportPublic FDA data

PRELUDE

Primary DI
00816594021709
Brand
PRELUDE
Company
DANVILLE MATERIALS, LLC
Model
91653
Catalog number
91653
Device description
PRELUDE,ONE,5ML
Published
2016-06-22
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
KLEAGENT, TOOTH BONDING, RESIN

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816594021709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816594021709008165940217098165940217090816594021709

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature074 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)743-7744xxx@xxx.xxx

Regulatory Flags#

DUNS number
601302743
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
00816594020122ACCOLADE90546905462016-06-22
00816594020238ACCOLADE90551905512016-06-22
00816594021655PRELUDE90976909762016-06-22
00816594021662PRELUDE90974909742016-06-22
00816594021679PRELUDE94036940362016-06-22
00816594021686PRELUDE94072940722016-06-22
00816594021693PRELUDE94037940372016-06-22
00816594021716PRELUDE91657916572016-06-22
00816594021723PRELUDE90972909722016-06-22
00816594021730PRELUDE94035940352016-06-22
00816594021747PRELUDE91024910242016-06-22
00816594021754PRELUDE90990909902016-06-22
00816594021761PRELUDE90994909942016-06-22
00816594021839S-BOND89104891042016-06-22
00816594021907ZBOND93410934102016-06-22
00816594023369PONTIC90138901382016-09-20
00816594020825TURBO TEMP 290156901562016-06-22
00816594020832TURBO TEMP 292964929642016-06-22
00816594020849TURBO TEMP 290158901582016-06-22
00816594020856TURBO TEMP 290631906312016-06-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
07615208296143Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297362ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297379ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208302684SyntacIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-03-29
10371347008729Advance Dental ProductsThe Atlanta Dental Supply CompanyKLE2022-12-29