FDA.reportPublic FDA data

FineEtch

Primary DI
08809262954012
Brand
FineEtch
Company
Spident Co., Ltd.
Model
SPIDENT FINE ETCH 37 - 1.2 4ea
Catalog number
#3601P04
Device description
FineEtch - 10, 37 is a phosphoric acid (H3PO4) semi-gel-type agent intended for use on dentin and enamel. FineEtch will effectively remove the smear layer and help successful bonding.
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08809262954012PrimaryGS10
08809262954043Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809262954012088092629540128809262954012
08809262954043088092629540438809262954043

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solution syringeA hand-held, manual dental instrument consisting of a barrel (cylinder) with plunger intended to be used to dispense dental etching solution (etchant) to a patient’s tooth/teeth. It is intended to be filled once and used on multiple patients; disposable dispensing tips may be included. This device is reusable until the contents of the syringe are exhausted.

Regulatory Flags#

DUNS number
689370711
Device count
4
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
08809262953602EsCemEsCem A22026-04-29
08809262953619EsCemEsCem A32026-04-29
08809262953626EsCemEsCem TW2026-04-29
08809262959000Temro.FlowTemp it Flow+ yellow 4ea2026-04-28
08809262959017Temro.FlowTemp it Flow+ Blu 4ea2026-04-28
08809262953206EsCom250EsCom250 A1#3203A12026-04-21
08809262953213EsCom250EsCom250 A2#3203A22026-04-21
08809262953220EsCom250EsCom250 A3#3203A32026-04-21
08809262953237EsCom250EsCom250 A3.5#3203A352026-04-21
08809262953244EsCom250EsCom250 A4#3203A42026-04-21
08809262953251EsCom250EsCom250 B1#3203B12026-04-21
08809262953268EsCom250EsCom250 B2#3203B22026-04-21
08809262953275EsCom250EsCom250 C2#3203C22026-04-21
08809262953282EsCom250EsCom250 D2#3203D22026-04-21
08809262953299EsCom250EsCom250 G1#3203G12026-04-21
08809262953305EsCom250EsCom250 AO2#3203AO22026-04-21
08809262953312EsCom250EsCom250 AO3#3203AO32026-04-21
08809262953329EsCom250EsCom250 TW#3203TW2026-04-21
08809262953336EsCom250EsCom250 Capsule A1 20ea#3203A1PCA2026-04-21
08809262953343EsCom250EsCom250 Capsule A2 20ea#3203A2PCA2026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
14548161075664G-Bond ™Gc America Inc.KLE2022-10-11