Dental Lithium Disilicate Glass Ceramic

GUDID 06978137012569

Liaoning Rachcera Material Technology Co.,Ltd.

Dental appliance fabrication material, combination-material

• Primary Device ID: 06978137012569
• NIH Device Record Key: 3af37e1f-db0d-4b66-947e-fddce5505c68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Lithium Disilicate Glass Ceramic
• Version Model Number: P-HT-D4 X(D13×10mm)
• Company DUNS: 616321064
• Company Name: Liaoning Rachcera Material Technology Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06978137012569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242740

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-28
• Device Publish Date: 2025-01-20

On-Brand Devices [Dental Lithium Disilicate Glass Ceramic]

• 06978137013085: P-HO-2 W(D13×10mm)
• 06978137013078: P-HO-1 W(D13×10mm)
• 06978137013061: P-HO-0 W(D13×10mm)
• 06978137013054: P-MO-4 W(D13×10mm)
• 06978137013047: P-MO-3 W(D13×10mm)
• 06978137013030: P-MO-2 W(D13×10mm)
• 06978137013023: P-MO-1 W(D13×10mm)
• 06978137013016: P-MO-0 W(D13×10mm)
• 06978137013009: P-MT-BL4 X(D13×10mm)
• 06978137012996: P-MT-BL3 X(D13×10mm)
• 06978137012989: P-MT-BL2 X(D13×10mm)
• 06978137012972: P-MT-BL1 X(D13×10mm)
• 06978137012965: P-MT-D4 X(D13×10mm)
• 06978137012958: P-MT-D3 X(D13×10mm)
• 06978137012941: P-MT-D2 X(D13×10mm)
• 06978137012934: P-MT-C4 X(D13×10mm)
• 06978137012927: P-MT-C3 X(D13×10mm)
• 06978137012910: P-MT-C2 X(D13×10mm)
• 06978137012903: P-MT-C1 X(D13×10mm)
• 06978137012897: P-MT-B4 X(D13×10mm)
• 06978137012880: P-MT-B3 X(D13×10mm)
• 06978137012873: P-MT-B2 X(D13×10mm)
• 06978137012866: P-MT-B1 X(D13×10mm)
• 06978137012859: P-MT-A4 X(D13×10mm)
• 06978137012842: P-MT-A3.5 X(D13×10mm)
• 06978137012835: P-MT-A3 X(D13×10mm)
• 06978137012828: P-MT-A2 X(D13×10mm)
• 06978137012811: P-MT-A1 X(D13×10mm)
• 06978137012804: P-LT-BL4 X(D13×10mm)
• 06978137012798: P-LT-BL3 X(D13×10mm)
• 06978137012781: P-LT-BL2 X(D13×10mm)
• 06978137012774: P-LT-BL1 X(D13×10mm)
• 06978137012767: P-LT-D4 X(D13×10mm)
• 06978137012750: P-LT-D3 X(D13×10mm)
• 06978137012743: P-LT-D2 X(D13×10mm)
• 06978137012736: P-LT-C4 X(D13×10mm)
• 06978137012729: P-LT-C3 X(D13×10mm)
• 06978137012712: P-LT-C2 X(D13×10mm)
• 06978137012705: P-LT-C1 X(D13×10mm)
• 06978137012699: P-LT-B4 X(D13×10mm)
• 06978137012682: P-LT-B3 X(D13×10mm)
• 06978137012675: P-LT-B2 X(D13×10mm)
• 06978137012668: P-LT-B1 X(D13×10mm)
• 06978137012651: P-LT-A4 X(D13×10mm)
• 06978137012644: P-LT-A3.5 X(D13×10mm)
• 06978137012637: P-LT-A3 X(D13×10mm)
• 06978137012620: P-LT-A2 X(D13×10mm)
• 06978137012613: P-LT-A1 X(D13×10mm)
• 06978137012606: P-HT-BL4 X(D13×10mm)
• 06978137012590: P-HT-BL3 X(D13×10mm)