Fixture Mount Kit
Dental · 21 CFR 872.3980
Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
16 firms currently registered for this product code
Zhuhai Meierjing Medical Instrument Co., Ltd.
Zhuhai Guangdong, CN
Osstem Implant Co., Ltd.
Haeundae-gu Busan, KR
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Hans Korea
Paju-si Gyeonggi, KR
Isomedix Operations Inc
El Paso, TX, US
Megagen Implant Co., Ltd. (research Laboratories)
Daegu, KR
Megagen Implant Co., Ltd.
Daegu, KR
Osstem Implant Co., Ltd.
Gangseo-gu Seoul, KR
Bio Concept Co., Ltd.
Changzhou Jiangsu, CN
Isomedix Operations Inc
EL PASO, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Cardinal Health 200, Llc
El Paso, TX, US
3d Diagnostix Inc
Allston, MA, US
Sterigenics U.s., Llc
Charlotte, NC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Ffdm Tivoly
BOURGES CEDEX Centre-Val de Loire, FR
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.