FDA UDI
In Commercial Distribution
🇺🇸 United States
IMTEC
DI: D76922140
·
Model: 2214-CO
·
PARK DENTAL RESEARCH CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMTEC
- Primary DI
- D76922140
- Version / Model
- 2214-CO
- Company Name
- PARK DENTAL RESEARCH CORP
- Labeler DUNS
- 011441508
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-03
- Public Version
- 1
- Public Version Date
- 2024-05-13
- Public Version Status
- New
- Public Device Record Key
- f1909f1a-9668-4187-ab5c-b6bb7557f2a0
Device Description
2.25 mm x 14 mm Collared Implant
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55772 | Organic solvent metabolite IVD, kit, liquid chromatography | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple metabolites/biomarkers associated with occupational or environmental exposure to volatile organic solvents (e.g., benzene, styrene, toluene, xylene) in a clinical specimen, using a liquid chromatography method. Compounds detected typically include phenol, cresol, hippuric acid, methylhippuric acid, mandelic acid, muconic acid, and/or phenylglyoxylic acid; detection of polycyclic aromatic hydrocarbon (PAH) metabolites is not included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D76922140 | HIBCC |
Customer Contacts
- Phone
- 800-243-7372
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121707 | 000 |