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NexxZr®+ Coloring Liquids / NexxZr+ Coloring Liquid A1 60ml

FDA UDI

Class II (US FDA UDI)

by Sagemax Bioceramics, Inc.

Identity

Trade Name
NexxZr®+ Coloring Liquids / NexxZr+ Coloring Liquid A1 60ml FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Model / Reference
NPC060A10 FDA UDI

Identifiers

Primary DI / UDI-DI
00842271161543 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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

NexxZr®+ Coloring Liquids / NexxZr+ Coloring Liquid A1 60ml by Sagemax Bioceramics, Inc. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K130991 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sagemax Bioceramics, Inc.

Sources (1)

  • FDA UDI 1bb7b6ca-798a-43a4-9191-889100e7e4fb 34 fields · synced May 31, 2026