FDA.reportPublic FDA data

Acid Etchant

Primary DI
00190746061363
Brand
Acid Etchant
Company
AMERICAN ORTHODONTICS CORPORATION
Model
020-041465
Catalog number
020-041465
Device description
ADHESIVE ACID ETCHANT GEL GREEN 37% 2ml SYRINGE AND TIPS
Published
2026-10-30
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

Contact Domains#

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
K172953000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172953000Acid EtchantAmerican Orthodontics2018-02-06KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190746061363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190746061363001907460613631907460613630190746061363

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-7687info@americanortho.com

Regulatory Flags#

DUNS number
044668515
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
00190746202841Tanzo TriForce827-3X1U-1425PSW827-3X1U-1425PSW2026-10-29
00190746202858Tanzo TriForce827-3X1U-1425W827-3X1U-1425W2026-10-29
00190746202865Tanzo TriForce827-3X1U-1616PSW827-3X1U-1616PSW2026-10-29
00190746202872Tanzo TriForce827-3X1U-1616W827-3X1U-1616W2026-10-29
00190746202889Tanzo TriForce827-3X1U-1622W827-3X1U-1622W2026-10-29
00190746202896Tanzo TriForce827-3X1U-1725W827-3X1U-1725W2026-10-29
00190746202902Tanzo TriForce827-3X1U-1818PSW827-3X1U-1818PSW2026-10-29
00190746202919Tanzo TriForce827-3X1U-1818W827-3X1U-1818W2026-10-29
00190746202926Tanzo TriForce827-3X1U-1825W827-3X1U-1825W2026-10-29
00190746202933Tanzo TriForce827-3X1U-1925W827-3X1U-1925W2026-10-29
00190746202940Tanzo TriForce827-3X1U-2020PSW827-3X1U-2020PSW2026-10-29
00190746202957Tanzo TriForce827-3X1U-2020W827-3X1U-2020W2026-10-29
00190746202964Tanzo TriForce827-3X3L-1425PSW827-3X3L-1425PSW2026-10-29
00190746202971Tanzo TriForce827-3X3L-1425W827-3X3L-1425W2026-10-29
00190746202988Tanzo TriForce827-3X3L-1616PSW827-3X3L-1616PSW2026-10-29
00190746202995Tanzo TriForce827-3X3L-1616W827-3X3L-1616W2026-10-29
00190746203008Tanzo TriForce827-3X3L-1622W827-3X3L-1622W2026-10-29
00190746203015Tanzo TriForce827-3X3L-1725W827-3X3L-1725W2026-10-29
00190746203022Tanzo TriForce827-3X3L-1818PSW827-3X3L-1818PSW2026-10-29
00190746203039Tanzo TriForce827-3X3L-1818W827-3X3L-1818W2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970006745660Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06970006746568Phosphoric Acid Etching GelRizhao 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
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