Identity
- Trade Name
- NexxZr™ S / Z-95-20-NS-OM30-SD FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511# FDA UDI
- Model / Reference
- Z-42204 FDA UDI
- Description
- https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511# FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842271100948 FDA UDI
- 510(k) Number
- K130991 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NexxZr™ S / Z-95-20-NS-OM30-SD by Sagemax Bioceramics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K130991 also covers:
- NexxZr™ Plus / Z-95-14-NP-D400-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ Plus / Z-95-16-NP-WT00-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ Plus / Z-95-18-NP-A350-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ T / D-100-12-NT-OM20-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ T / H-100-22-NT-OM10-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ T / H-100-25-NT-C100-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ T / H-100-30-NT-OM30-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ T / R-76-16-NT-A300-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ T / W-98-12-NT-C100-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ T / W-98-18-NT-D200-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ T / Z-95-12-NT-C100-SD — SAGEMAX BIOCERAMICS, INC.
- NexxZr™ T / Z-95-14-NT-B200-SD — SAGEMAX BIOCERAMICS, INC.
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
- Sagemax Bioceramics, Inc.
Sources (1)
- FDA UDI 900c449f-7cbb-402d-a2c7-3cf9c1fa2664 35 fields · synced Jun 8, 2026