FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Quick Set Paste A & B
DI: D867CLQSP0
·
Model: CLQSP
·
Xemax Surgical Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Quick Set Paste A & B
- Primary DI
- D867CLQSP0
- Version / Model
- CLQSP
- Catalog Number
- CLQSP
- 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
- 4
- Public Version Date
- 2025-09-01
- Public Version Status
- Update
- Public Device Record Key
- 2b6e918d-3138-48b7-9aaf-d8116809bf52
- Distribution End Date
- 2025-08-29
Device Description
Quick Set Paste is intended for use as an orthodontic bonding adhesive for brackets and appliances.
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 |
|---|---|---|---|---|
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | Dental | 872.3750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31750 | Orthodontic bracket adhesive | A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. 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 | D867CLQSP0 | HIBCC |
Customer Contacts
- Phone
- +0117072247817
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature (15-30 Degrees C / Not to exceed 86 Degrees F)