Ceri-Sander™ 031337510

GUDID D8130313375100

CERISANDER STRIPS FINE 6pc LG

DEN-MAT HOLDINGS, LLC

Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use Dental abrasive strip, single-use

• Primary Device ID: D8130313375100
• NIH Device Record Key: 3bace851-b97c-459c-8fb6-537f0ba49d9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceri-Sander™
• Version Model Number: 031337510
• Catalog Number: 031337510
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 6
• DM Exempt: false
• 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

Customer Support Contacts

• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130313375100 [Unit of Use]
HIBCC	D8130313375101 [Primary]

FDA Product Code

• DZB: Headgear, Extraoral, Orthodontic

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: 2022-09-30
• Device Publish Date: 2022-09-22

On-Brand Devices [Ceri-Sander™]

• D8130313475200: C-SNDR POST STRIPS UFINE 6pcSM
• D8130313475100: C-SNDR POST STRIPS FINE 6pc SM
• D8130313475000: CERISNDR POSTERIOR KIT w/STRPS
• D8130313375200: CERISANDER STRIPS U-FINE 6pcLG
• D8130313375100: CERISANDER STRIPS FINE 6pc LG
• D8130313375000: CERISNDER ANTERIOR KIT w/STRPS