FDA UDI
In Commercial Distribution
🇺🇸 United States
TRI-CAM Dental Implant System
DI: 00614950027675
·
Model: 3035S
·
ACE SURGICAL SUPPLY CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- TRI-CAM Dental Implant System
- Primary DI
- 00614950027675
- Version / Model
- 3035S
- Catalog Number
- 3035S
- Company Name
- ACE SURGICAL SUPPLY CO., INC.
- Labeler DUNS
- 042763706
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-06-16
- Public Version
- 1
- Public Version Date
- 2023-06-26
- Public Version Status
- New
- Public Device Record Key
- 03d4279d-457d-48e2-9607-b43c16908604
Device Description
TRI-CAM TITANIUM SCREW FOR 3.5MM 5/PKG
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
- No
- 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 |
|---|---|---|---|---|
| 55848 | Screw endosteal dental implant, one-piece | A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10614950027672 | GS1 | ||||
| Primary | 00614950027675 | GS1 |
Customer Contacts
- Phone
- +1(508)588-3100 ext. 715
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.5 | Millimeter |