Blade-Form Endosseous Dental Implant
The Blade-Form Endosseous Dental Implant is a surgically placed device made from materials such as titanium or titanium alloy, designed to be inserted into the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, restoring a patient's chewing function. It is an FDA Class 2 implant regulated under 21 CFR 872.3640 in the Dental specialty, with product code NRQ, requiring 510(k) clearance. The implant flag is set, reflecting its nature as a surgically implanted device. It does not carry a life-sustaining support designation.
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Basic Information
- Product Code
- NRQ
- Device Class
- FDA class 2
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
Definition
Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K211872 | PiezoImplant System | Oct 12, 2022 | Substantially Equivalent | Rex Implants, Inc. |
| K981954 | VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS | Jan 25, 1999 | Substantially Equivalent | Healthline Implants, Inc. |
| K822969 | GENERATION 5 LINKOW BLADE IMPLANTS | Nov 04, 1982 | Substantially Equivalent | Leonard P. Linkow, D.D.L. |
| K791366 | ORATRONICS ENDOSSEOUS FRAME ASSEMBLY | Oct 09, 1979 | Substantially Equivalent | Oratronics, Inc. |
| K791204 | MITER ENDOSTEAL BLADE IMPLANT | Sep 28, 1979 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.