PacEtch

GUDID 00815967022411

PacEtch Etching Gel

Pac-Dent, Inc.

Dental tooth-etching solution

• Primary Device ID: 00815967022411
• NIH Device Record Key: 48155f53-9ff8-4789-a7d3-f73f24e0f6b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PacEtch
• Version Model Number: 135-C
• Company DUNS: 080104787
• Company Name: Pac-Dent, 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: 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	00815967022411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200462

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [PacEtch]

• 00815967022589: PacEtch Etching Gel Syringes with Pre-Bent Neddle Tips
• 00815967022411: PacEtch Etching Gel
• 00815967022404: PacEtch Etching Gel Economic Pack