FDA UDI
In Commercial Distribution
🇺🇸 United States
Jade
DI: 00353045000628
·
Model: 20-00005
·
DHARMA RESEARCH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Jade
- Primary DI
- 00353045000628
- Version / Model
- 20-00005
- Catalog Number
- 20-00005
- Company Name
- DHARMA RESEARCH, INC.
- Labeler DUNS
- 078444642
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 4
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- 34aef14f-921e-4e8e-a797-d6969972b0f2
Device Description
Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe, 50 Pre-bent 23ga Tips, 4 x 1.2ml Empty Syringes & Instruction Insert Instruction Insert
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36153 | Dental tooth-etching solution | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10353045000625 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 00353045000628 | GS1 |
Customer Contacts
- Phone
- +3054829669
- [email protected]
- Phone
- 8778333725
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150696 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 50 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius