EZCrown

GUDID 00819235020765

Sprig Posterior Crown -Mandibular Left Second Molar

Sprig Oral Health Technologies, Inc.

Preformed dental crown, temporary

• Primary Device ID: 00819235020765
• NIH Device Record Key: dcf542e7-c0ea-44b2-8e23-e37a0fb6ea16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZCrown
• Version Model Number: R-EZC-P-K6
• Company DUNS: 029458526
• Company Name: Sprig Oral Health Technologies, Inc.
• 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: 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	00819235020765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091362

FDA Product Code

• ELZ: Crown, Preformed

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: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [EZCrown]

• 00819235021540: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid (Space Loss)
• 00819235021533: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid
• 00819235021526: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid (Space Loss)
• 00819235021519: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid
• 00819235021502: Sprig Anterior Crown -Maxillary Left Lateral
• 00819235021496: Sprig Anterior Crown -Maxillary Left Lateral
• 00819235021489: Sprig Anterior Crown -Maxillary Left Lateral
• 00819235021472: Sprig Anterior Crown -Maxillary Left Lateral
• 00819235021465: Sprig Anterior Crown -Maxillary Left Lateral
• 00819235021458: Sprig Anterior Crown -Maxillary Left Lateral
• 00819235021441: Sprig Anterior Crown -Maxillary Left Central
• 00819235021434: Sprig Anterior Crown -Maxillary Left Central
• 00819235021427: Sprig Anterior Crown -Maxillary Left Central
• 00819235021410: Sprig Anterior Crown -Maxillary Left Central
• 00819235021403: Sprig Anterior Crown -Maxillary Left Central
• 00819235021397: Sprig Anterior Crown -Maxillary Left Central
• 00819235021380: Sprig Anterior Crown -Maxillary Right Central
• 00819235021373: Sprig Anterior Crown -Maxillary Right Central
• 00819235021366: Sprig Anterior Crown -Maxillary Right Central
• 00819235021359: Sprig Anterior Crown -Maxillary Right Central
• 00819235021342: Sprig Anterior Crown -Maxillary Right Central
• 00819235021335: Sprig Anterior Crown -Maxillary Right Central
• 00819235021328: Sprig Anterior Crown -Maxillary Right Lateral
• 00819235021311: Sprig Anterior Crown -Maxillary Right Lateral
• 00819235021304: Sprig Anterior Crown -Maxillary Right Lateral
• 00819235021298: Sprig Anterior Crown -Maxillary Right Lateral
• 00819235021281: Sprig Anterior Crown -Maxillary Right Lateral
• 00819235021274: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid (Space Loss)
• 00819235021267: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid
• 00819235021250: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid (Space Loss)
• 00819235021243: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid
• 00819235021236: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid (Space Loss)
• 00819235021229: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid
• 00819235021212: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid (Space Loss)
• 00819235021205: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid
• 00819235021199: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid (Space Loss)
• 00819235021182: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid
• 00819235021175: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid (Space Loss)
• 00819235021168: Sprig Posterior Crown -Mandibular or Maxillary Right Cuspid
• 00819235020017: Sprig Anterior Crown -Maxillary Right Lateral
• 00819235021663: Sprig Anterior Crown -Mandibular Universal (Incisors)
• 00819235021656: Sprig Anterior Crown -Mandibular Universal (Incisors)
• 00819235021649: Sprig Anterior Crown -Mandibular Universal (Incisors)
• 00819235021632: Sprig Anterior Crown -Mandibular Universal (Incisors)
• 00819235021625: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid (Space Loss)
• 00819235021618: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid
• 00819235021601: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid (Space Loss)
• 00819235021595: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid
• 00819235021588: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid (Space Loss)
• 00819235021571: Sprig Anterior Crown -Mandibular or Maxillary Left Cuspid