FDA.reportPublic FDA data

Phosphoric Acid Etching Gel

Primary DI
06970006746568
Brand
Phosphoric Acid Etching Gel
Company
Rizhao HuGe Biomaterials Company, Ltd.
Model
E37
Catalog number
1ml*1
Published
2026-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K221450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221450000Phosphoric Acid Etching GelRizhao Huge Biomaterials Company, Ltd.2022-09-12KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970006746568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970006746568069700067465686970006746568

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-etching solutionAn acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
544452689
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970006745660Light Cure Dental Adhesive/6ml2026-10-25
06970006745677Universal Composite Restorative/A2/4g/TrusFIL X-Blend2026-10-25
06970006746575TrusFIL-Flow Flowable Composite Restorative/DO/2g2026-10-25
06970006746582TrusFIL-Flow Flowable Composite Restorative/PR/2g2026-10-25
06970006746599TrusFIL-Flow Flowable Composite Restorative/Br/2g2026-10-25
06970006746605TrusFIL-Flow Flowable Composite Restorative/DR/2g2026-10-25
06970006746612TrusFIL-Flow Flowable Composite Restorative/LR/2g2026-10-25
06970006746629TrusFIL-Flow Flowable Composite Restorative/P1/2g2026-10-25
06970006746636TrusFIL-Flow Flowable Composite Restorative/P2/2g2026-10-25
06970006746643TrusFIL-Flow Flowable Composite Restorative/P3/2g2026-10-25
06970006746650TrusFIL-Flow Flowable Composite Restorative/YP/2g2026-10-25
06970006746667TrusFIL-Flow Flowable Composite Restorative/DP/2g2026-10-25
06970006746674TrusFIL-Flow Flowable Composite Restorative/LT/2g2026-10-25
06970006746681TrusFIL-Flow Flowable Composite Restorative/WO/2g2026-10-25
06970006746698TrusFIL-Flow Flowable Composite Restorative/WT/2g2026-10-25
06970006746704Universal Composite Restorative/DO/4g2026-10-25
06970006746711Universal Composite Restorative/PR/4g2026-10-25
06970006746728Universal Composite Restorative/DR/4g2026-10-25
06970006746735Universal Composite Restorative/LR/4g2026-10-25
06970006746742Universal Composite Restorative/P1/4g2026-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970006745660Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06972220488958Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
00840456224366JMUJMU DENTAL, INCKLE2026-07-22
00840456224441JMUJMU DENTAL, INCKLE2026-07-22
07615208570830Adhese 2 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-07-22
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
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306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
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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