FDA UDI
In Commercial Distribution
🇺🇸 United States
Calamus
DI: D716CALDUAL1
·
Model: CALDUAL
·
TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
14
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Calamus
- Primary DI
- D716CALDUAL1
- Version / Model
- CALDUAL
- Catalog Number
- CALDUAL
- Company Name
- TULSA DENTAL PRODUCTS LLC
- Labeler DUNS
- 942778564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 14
- Record Status
- Published
- Publish Date
- 2022-10-18
- Public Version
- 1
- Public Version Date
- 2022-10-26
- Public Version Status
- New
- Public Device Record Key
- c90a9e8b-58a1-4c25-9374-e7d5f63a0c97
Device Description
Calamus Dual 3D Obturation Sys
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKM | GUTTA-PERCHA | Dental | 872.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47750 | Warm-bonded endodontic obturation system | An assembly of devices designed to deliver preheated resin-based sealing, filling, and core materials into a root canal for direct warm bonding during an endodontic obturation procedure. It typically consists of a mains electricity (AC-powered) oven used to heat the preloaded oburators, a series of root canal sizers (verifiers) used for the selection of the appropriate obturator, and preloaded obturators; other materials may be included (e.g., self-etch sealer). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D716CALDUAL0 | HIBCC | ||||
| Primary | D716CALDUAL1 | HIBCC |