Product code NEI— Dental
ADD-ON CONDYLE
- Classification name
- Prosthesis, Condyle, Mandibular, Temporary
- Device class
- Class 2
- Regulation
- 21 CFR 872.4770
- Advisory panel
- Dental
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code NEI
FDA has cleared devices under product code NEI between 1999 and 2014, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2014
- 2008
- 2007
- 2004
- 2001
- 1999
Top applicants under product code NEI
Recent clearances under product code NEI
- K133285 — STRYKER TEMPORARY CONDYLAR PROSTHESIS
- K081747 — MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- K063181 — SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- K031701 — OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
- K002790 — ADD-ON CONDYLE
- K990667 — KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
- K990637 — SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
Data sourced from openFDA. This site is unofficial and independent of the FDA.