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Dental Lithium Disilicate Glass Ceramic

FDA UDI

Class II (US FDA UDI)

by Liaoning Rachcera Material Technology Co., Ltd.

Identity

Trade Name
Dental Lithium Disilicate Glass Ceramic FDA UDI
Generic Name
Dental appliance fabrication material, combination-material FDA UDI
Model / Reference
HT-D2 RC(40×15×15mm) FDA UDI

Identifiers

Primary DI / UDI-DI
06978137011340 FDA UDI
510(k) Number
K242740 FDA UDI
FDA Product Code
EIH FDA UDI
GMDN Term
Dental appliance fabrication material, combination-material 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, combination-material

Dental Lithium Disilicate Glass Ceramic by Liaoning Rachcera Material Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Dental appliance fabrication material, combination-material.

Cleared under the same submission

K242740 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Liaoning Rachcera Material Technology Co., Ltd.

Sources (1)

  • FDA UDI cc0359ed-660f-4970-bce3-4f411e127df1 33 fields · synced Jun 8, 2026