PMMA BLOCK

GUDID 06975187612091

Huliang(Shanghai) Biotech Co., Ltd.

Temporary dental crown/bridge

• Primary Device ID: 06975187612091
• NIH Device Record Key: e12da6a4-83a5-4f35-b8f5-8ad440a8bae1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMMA BLOCK
• Version Model Number: Shade:ML B2; Spec:98*20mm; Net Weight:175g
• Company DUNS: 412706288
• Company Name: Huliang(Shanghai) Biotech 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: false
• 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	06975187612091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223706

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2023-07-28
• Device Publish Date: 2023-07-20

On-Brand Devices [PMMA BLOCK]

• 06975187612855: Shade:ML C2; Spec:98*25mm; Net Weight:210g
• 06975187612848: Shade:ML C1; Spec:98*25mm; Net Weight:210g
• 06975187612817: Shade:ML B2; Spec:98*25mm; Net Weight:210g
• 06975187612800: Shade:ML B1; Spec:98*25mm; Net Weight:210g
• 06975187612770: Shade:ML A3; Spec:98*25mm; Net Weight:210g
• 06975187612763: Shade:ML A2; Spec:98*25mm; Net Weight:210g
• 06975187612756: Shade:ML A1; Spec:98*25mm; Net Weight:210g
• 06975187612732: Shade:Clear; Spec:98*25mm; Net Weight:210g
• 06975187612725: Shade:Pink; Spec:98*25mm; Net Weight:210g
• 06975187612619: Shade:B1; Spec:98*25mm; Net Weight:210g
• 06975187612589: Shade:A3; Spec:98*25mm; Net Weight:210g
• 06975187612572: Shade:A2; Spec:98*25mm; Net Weight:210g
• 06975187612565: Shade:A1; Spec:98*25mm; Net Weight:210g
• 06975187612558: Shade:BL; Spec:98*25mm; Net Weight:210g
• 06975187612138: Shade:ML C2; Spec:98*20mm; Net Weight:175g
• 06975187612121: Shade:ML C1; Spec:98*20mm; Net Weight:175g
• 06975187612091: Shade:ML B2; Spec:98*20mm; Net Weight:175g
• 06975187612084: Shade:ML B1; Spec:98*20mm; Net Weight:175g
• 06975187612053: Shade:ML A3; Spec:98*20mm; Net Weight:175g
• 06975187612046: Shade:ML A2; Spec:98*20mm; Net Weight:175g
• 06975187612039: Shade:ML A1; Spec:98*20mm; Net Weight:175g
• 06975187612015: Shade:Clear; Spec:98*20mm; Net Weight:175g
• 06975187612008: Shade:Pink; Spec:98*20mm; Net Weight:175g
• 06975187611414: Shade:ML C2; Spec:98*16mm; Net Weight:140g
• 06975187611407: Shade:ML C1; Spec:98*16mm; Net Weight:140g
• 06975187611377: Shade:ML B2; Spec:98*16mm; Net Weight:140g
• 06975187611346: Shade:ML A3; Spec:98*16mm; Net Weight:140g
• 06975187611339: Shade:ML A2; Spec:98*16mm; Net Weight:140g
• 06975187611322: Shade:ML B1; Spec:98*16mm; Net Weight:140g
• 06975187611315: Shade:ML A1; Spec:98*16mm; Net Weight:140g
• 06975187610134: Shade: C2; Spec:98*10mm; Net Weight:87g
• 06975187610127: Shade: C1; Spec:98*10mm; Net Weight:87g
• 06975187610110: Shade: B4; Spec:98*10mm; Net Weight:87g
• 06975187610097: Shade: B3; Spec:98*10mm; Net Weight:87g
• 06975187610080: Shade: B2; Spec:98*10mm; Net Weight:87g
• 06975187610073: Shade: B1; Spec:98*10mm; Net Weight:87g
• 06975187610066: Shade: A4; Spec:98*10mm; Net Weight:87g
• 06975187610059: Shade: A3.5; Spec:98*10mm; Net Weight:87g
• 06975187610042: Shade: A3; Spec:98*10mm; Net Weight:87g
• 06975187610035: Shade: A2; Spec:98*10mm; Net Weight:87g
• 06975187610011: Shade: BL; Spec:98*10mm; Net Weight:87g
• 06975187610004: Shade: A1; Spec:98*10mm; Net Weight:87g