FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Etchant Gel
DI: D867CLEG0
·
Model: CLEG
·
Xemax Surgical Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Etchant Gel
- Primary DI
- D867CLEG0
- Version / Model
- CLEG
- Catalog Number
- CLEG
- Company Name
- Xemax Surgical Products Inc
- Labeler DUNS
- 804495695
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-22
- Public Version
- 5
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- 7d9904b9-e900-4967-ae3a-92d31070aa38
- Distribution End Date
- 2025-08-29
Device Description
Etchant Gel is 37% phosphoric acid (H3PO4) polymer-thickened and intended for use on enamel to prepare the surface for bonding. 9g etch in bottle.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | D867CLEG0 | HIBCC |
Customer Contacts
- Phone
- +0117072247817
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature (15-30 Degrees C )