Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1328959113
Device Listing 1328959113
Listing Summary
#
Listing key
1328959113
Premarket submission
K222144
Device
IR SLA Type Implant System
Applicant
Biotem Co., Ltd.
Product code
DZE
Decision date
2023-06-14
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
217342
3009611645
3009611645
BIOTEM CO., LTD.
1
N
2026-01-01
# 422, Sasang-ro, Sasang-gu Busan KR 46925