Identity
- Trade Name
- Estar-ZE FDA UDI
- Generic Name
- Custom-made dental crown, ceramic FDA UDI
- Model / Reference
- ZEHTA2020T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800209338933 FDA UDI
- 510(k) Number
- K242521 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Custom-made dental crown, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Custom-made dental crown, ceramic
Estar-ZE by OSSTEM IMPLANT Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made dental crown, ceramic.
- Restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- KATANA Zirconia — Institut Straumann SA · Class II
- Denture, Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
- All-Ceramic Crown — Beijing Yingguan Dental Technology Co., Ltd. · N
- Restoration, orthodontic — Modern Dental Laboratory (DG) Co., Ltd. · N
- Denture, retoration — Modern Dental Laboratory (DG) Co., Ltd. · N
- Estar-Z — OSSTEM IMPLANT Co., Ltd. · Class II
- Estar-Z — OSSTEM IMPLANT Co., Ltd. · Class II
Cleared under the same submission
K242521 also covers:
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
- Estar-ZE — OSSTEM IMPLANT Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (1)
- FDA UDI 65143cc7-fe79-44a1-8805-89b771eadc20 33 fields · synced Jun 6, 2026