FDA.reportPublic FDA data

Jade

Primary DI
10353045000649
Brand
Jade
Company
DHARMA RESEARCH, INC.
Model
20-00003
Catalog number
20-00003
Device description
Jade Blue 37% Phosphoric Acid Etchant Gel Kit - 4 x 1.2ml Syringes, 20 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
Rx
false
OTC
false
Sterile
false
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
10353045000649PackageGS148In Commercial Distribution
00353045000642PrimaryGS10
00353045002622Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035304500064910353045000649
00353045000642003530450006423530450006420353045000642
00353045002622003530450026223530450026220353045002622

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078444642
Device count
4
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
00353045000703Jade20-0000920-000092016-10-07
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
10353045000656Jade20-0000420-000042016-10-07
10353045000663Jade20-0000120-000012016-10-07
10353045000670Jade20-0000620-000062016-10-07

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J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
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