FDA UDI
In Commercial Distribution
🇺🇸 United States
PiezoImplant System
DI: D894B2094C0
·
Model: REX BL 2.9 x 4 H9
·
Rex Implants, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PiezoImplant System
- Primary DI
- D894B2094C0
- Version / Model
- REX BL 2.9 x 4 H9
- Catalog Number
- B2-094C
- Company Name
- Rex Implants, Inc.
- Labeler DUNS
- 080746478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-24
- Public Version
- 1
- Public Version Date
- 2023-01-02
- Public Version Status
- New
- Public Device Record Key
- 00925ccb-2d85-44b6-9f2e-a76183c36924
Device Description
REX BL 2.9 x 4 H9 packaged with Cover Screw BL 2.9
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
- MR Conditional
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| NRQ | Blade-Form Endosseous Dental Implant | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55847 | Dental implant system | A collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D894B2094C0 | HIBCC |
Customer Contacts
- Phone
- 6146538429
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211872 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 9 | Millimeter | |
| Width | 4 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius