Easy Grip Dental Implant System
510(k) K073622
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073622 | Date14 May 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Easy Grip Dental Implant System is a root-form endosseous dental implant system designed for dental implantation procedures. It consists of implants and related surgical accessories manufactured by T.F.I. System S.R.L.
The system is supplied as a medical device with FDA 510(k) clearance (K073622) and is intended for dental implantation. The implants are fabricated from unspecified materials and are available in various sizes as indicated by the model numbers in the specifications. The device is regulated under product code DZE and was cleared by the FDA in 2008.
Questions
AI-generated answers, 22 Sep 2026
What is the Easy Grip Dental Implant System used for?
The Easy Grip Dental Implant System is a root-form endosseous dental implant system designed for dental implantation procedures. It consists of implants and related surgical accessories manufactured by T.F.I. System S.R.L.
What regulatory approvals does the Easy Grip Dental Implant System have?
The system is supplied as a medical device with FDA 510(k) clearance (K073622) and is regulated under product code DZE. It was cleared by the FDA in 2008.
What materials are the implants made of and what sizes are available?
The implants are fabricated from unspecified materials and are available in various sizes as indicated by the model numbers in the specifications.
Is the Easy Grip Dental Implant System single-use or reusable?
The device information does not specify whether the Easy Grip Dental Implant System is designed for single-use or reuse. Clinicians should refer to the manufacturer's instructions for use for proper handling and sterilization protocols.