FDA UDI
In Commercial Distribution
🇺🇸 United States
AdDent
DI: D8691300001
·
Model: Compex HD
·
ADDENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AdDent
- Primary DI
- D8691300001
- Version / Model
- Compex HD
- Catalog Number
- 130000
- Company Name
- ADDENT, INC.
- Labeler DUNS
- 099490679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-22
- Public Version
- 1
- Public Version Date
- 2026-04-30
- Public Version Status
- New
- Public Device Record Key
- 2ad24e87-6c83-4b55-96df-d763e7b1506d
Device Description
The Compex HD unit is intended to be used by a dentist or health care provider to warm and dispense dental composite materials contained in a compule or PLT (Pre-Loaded Tip) to 155 degrees F (68 degrees C).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QGO | Composite Resin Warmer | Dental | 872.6100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16196 | Dental material cartridge-plunging applicator, single-component | A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8691300001 | HIBCC |
Customer Contacts
- Phone
- 2037780200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182017 | 000 |