FDA.reportPublic FDA data

STAE

Primary DI
09336472012564
Brand
STAE
Company
SDI LIMITED
Model
8100201
Catalog number
8100201
Device description
STAE 5ML PK
Published
2025-01-08
Public version status
New
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
K973092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973092000STAESouthern Dental Industries, Inc.1997-12-08KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09336472012564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09336472012564093364720125649336472012564

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 may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage conditions 10°C - 25°C (50 - 77°F)

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
753221852
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
29336472004747BENCO ADMIX510230351023032026-02-17
29336472004754BENCO SPHERICAL510236351023632026-02-17
29336472004860BENCO ADMIX512230351223032026-02-17
29336472004877BENCO SPHERICAL512236351223632026-02-17
09336472005450RIVA CEM AUTOMIX880070488007042026-02-16
09336472005474ULTRAMAT 2554604555460452026-02-16
09336472020965RIVA CEM AUTOMIX880070388007032026-02-16
09336472032203RIVA CEM880070088007002026-02-16
09336472038212RIVA STAR880050488005042026-02-16
09336472038366RIVA STAR AQUA880052788005272026-02-16
09336472038403RIVA STAR AQUA880053288005322026-02-16
09336472038441RIVA STAR880053788005372026-02-16
D662070830158PD ADMIX400002540000252026-02-17
D662070830166PD ADMIX400002640000262026-02-17
D662070830273PD ADMIX400000540000052026-02-17
D662070830281PD ADMIX400000640000062026-02-17
D662070900258PD SPHERICAL400006540000652026-02-17
D662070900266PD SPHERICAL400006640000662026-02-17
D662070900373PD SPHERICAL400004540000452026-02-17
D662070900381PD SPHERICAL400004640000462026-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07615208296143Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297362ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297379ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06