DuraLock® PLUS Impression Trays

GUDID 00190707099305

DuraLock® PLUS Impression Tray - Size: 1 Pedo, RED Upper

Ortho Organizers, Inc.

Dental impression tray, reusable

• Primary Device ID: 00190707099305
• NIH Device Record Key: d42735eb-daa2-45d9-8c64-85c8c535e78c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraLock® PLUS Impression Trays
• Version Model Number: 640-041
• Company DUNS: 062165188
• Company Name: Ortho Organizers, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00190707099305 [Primary]

FDA Product Code

• EHY: TRAY, IMPRESSION, PREFORMED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-12-19
• Device Publish Date: 2022-01-06

On-Brand Devices [DuraLock® PLUS Impression Trays]

• 00190707099411: DuraLock® PLUS Impression Tray - Size: 6 Extra Large, PURPLE Lower
• 00190707099404: DuraLock® PLUS Impression Tray - Size: 5 Large, YELLOW Lower
• 00190707099398: DuraLock® PLUS Impression Tray - Size: 4 Medium, GREEN Lower
• 00190707099381: DuraLock® PLUS Impression Tray - Size: 3 Small, BLUE Lower
• 00190707099374: DuraLock® PLUS Impression Tray - Size: 2 Extra Small, ORANGE Lower
• 00190707099367: DuraLock® PLUS Impression Tray - Size: 1 Pedo, RED Lower
• 00190707099350: DuraLock® PLUS Impression Tray - Size: 6 Extra Large, PURPLE Upper
• 00190707099343: DuraLock® PLUS Impression Tray - Size: 5 Large, YELLOW Upper
• 00190707099336: DuraLock® PLUS Impression Tray - Size: 4 Medium, GREEN Upper
• 00190707099329: DuraLock® PLUS Impression Tray - Size: 3 Small, BLUE Upper
• 00190707099312: DuraLock® PLUS Impression Tray - Size: 2 Extra Small, ORANGE Upper
• 00190707099305: DuraLock® PLUS Impression Tray - Size: 1 Pedo, RED Upper
• 00190707099299: DuraLock® PLUS Impression Trays Assortment