← Back to catalogue

Obsidian

FDA UDI

Class II (US FDA UDI)

by Prismatik Dentalcraft, Inc.

Identity

Trade Name
Obsidian FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
Obsidian Milling Block 5-Pack W14 C-Mandrel D3 HS FDA UDI
Model / Reference
70-1122-SHS0099 FDA UDI
Description
Obsidian Milling Block 5-Pack W14 C-Mandrel D3 HS FDA UDI

Identifiers

Catalog Number
70-1122-SHS0099 FDA UDI
Primary DI / UDI-DI
D745701122SHS00991 FDA UDI
510(k) Number
K141788 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 14 Millimeter FDA UDI

Obsidian by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K141788 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Prismatik Dentalcraft, Inc.

Sources (1)

  • FDA UDI 550e4186-ff22-4235-a790-eff8b9d98de7 38 fields · synced Jun 1, 2026