FDA.reportPublic FDA data

Jade

Primary DI
00353045002127
Brand
Jade
Company
DHARMA RESEARCH, INC.
Model
20-00016
Catalog number
20-00016
Device description
Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe & Instruction Insert
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150696000Jade 37% Phosphoric Acid Etchant GelDharma Research, Inc.2015-06-23KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10353045002124PackageGS125In Commercial Distribution
00353045002127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035304500212410353045002124
00353045002127003530450021273530450021270353045002127

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8778333725info@dharmaresearch.com
+3054829669rcarles@dharmaresearch.com

Regulatory Flags#

DUNS number
078444642
Device count
1
DM exempt
true
Kit
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
00353045001083Qartz58-0020058-002002026-10-14
00353045001090Qartz58-0020158-002012026-10-14
00353045001106Qartz58-0020258-002022026-10-14
00353045001113Qartz58-0020358-002032026-10-14
00353045001120Qartz58-0020458-002042026-10-14
00353045001137Qartz58-0020558-002052026-10-14
00353045001144Qartz58-0020658-002062026-10-14
00353045001151Qartz58-0020758-002072026-10-14
00353045001175Qartz58-0020958-002092026-10-14
00353045001182Qartz58-0021058-002102026-10-14
00353045001212Qartz58-0021358-002132026-10-14
00353045001229Qartz58-0021458-002142026-10-14
00353045001236Qartz58-0022458-002242026-10-14
00353045000550Qartz58-0003158-000312026-10-13
00353045000567Qartz58-0003258-000322026-10-13
00353045000598Qartz58-0005158-000512026-10-13
00353045000932Qartz58-0005258-000522026-10-13
00353045000949Qartz58-0005758-000572026-10-13
00353045001168Qartz58-0020858-002082026-10-13
00353045003773Qartz58-0013258-001322026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14