FDA.reportPublic FDA data

Jade

Primary DI
00353045000703
Brand
Jade
Company
DHARMA RESEARCH, INC.
Model
20-00009
Catalog number
20-00009
Device description
Jade Green 37% Phosphoric Acid Etchant Gel - 25 x 1.2ml Syringes, 50 Pre-bent 23ga Tips & 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
10353045000700PackageGS130In Commercial Distribution
00353045000703PrimaryGS10
00353045002639Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035304500070010353045000700
00353045000703003530450007033530450007030353045000703
00353045002639003530450026393530450026390353045002639

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 Volume1.2Milliliter

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
25
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
00353045000628Jade20-0000520-000052016-10-07
00353045000635Jade20-0000220-000022016-10-07
00353045000642Jade20-0000320-000032016-10-07
00353045000659Jade20-0000420-000042016-10-07
00353045000666Jade20-0000120-000012016-10-07
00353045000673Jade20-0000620-000062016-10-07
00353045000680Jade20-0000720-000072016-10-07
00353045000697Jade20-0000820-000082016-10-07
00353045002127Jade20-0001620-000162016-10-07
00353045002134Jade20-0009120-000912016-10-07
00353045000710Jade20-0001020-000102016-10-07
00353045002349Citrine56-0020056-002002016-10-07
00353045002356Citrine56-0020256-002022016-10-07
00353045002363Citrine56-0020456-002042016-10-07
10353045000625Jade20-0000520-000052016-10-07
10353045000632Jade20-0000220-000022016-10-07
10353045000649Jade20-0000320-000032016-10-07
10353045000656Jade20-0000420-000042016-10-07
10353045000663Jade20-0000120-000012016-10-07
10353045000670Jade20-0000620-000062016-10-07

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Primary DI, Brand, Company table
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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
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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
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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