Company
Korea (the Republic of)DENTIS Co., LTD Medical Division, Dong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for DENTIS Co., LTD Medical Division in Dong. 3 FDA inspections on record, 1 Form 483, last inspected September 10, 2026.
Company Profile
This profile covers DENTIS Co., LTD Medical Division based in Dong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 16, 2017. Last inspected September 10, 2026.
Most cited issue areas
- Design and development verification plans not documented1 inspection
- Monitoring, measurement, analysis, and improvement processes not adequate1 inspection
- Records of equipment calibration and verification not maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 10, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1336240 |
| January 25, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1229378 |
| November 16, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1036194 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
DENTIS Co., LTD Medical Division
FEI Number
3010373494
Address
6 Yuram-Ro, Dong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 289c9519-e1cf-4b4e-997b-f52fe51ec561