DenMat® CR0002

GUDID D813CR00020

MTX RFL NEDLS 20GA 100BG

DEN-MAT HOLDINGS, LLC

Dental matrix band retainer

• Primary Device ID: D813CR00020
• NIH Device Record Key: 4992e61b-b91f-45b8-8f7b-c6a56821f947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DenMat®
• Version Model Number: CR0002
• Catalog Number: CR0002
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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	D813CR00020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K772316

FDA Product Code

• DZN: Instruments, Dental Hand

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 [DenMat®]

• D813SPD19100: MXTIP GREEN 25pc LITE XLITE
• D813SPD19090: MXTIP PURP 25pc HVY MED BITERG
• D813SPD15260: BASE 20gm JAR
• D813SPD15250: CATALYST 20gm JAR
• D813SPD11810: MIX TIP GREEN 50PK
• D813SPD11800: MIX TIP PURPLE 50PK
• D813SPD11780: PF TMP DISP GUN 4:1
• D813CR10661: BAG 25 PF TMP SYR GLD MIX TIPS
• D813CR10461: BAG OF 25 PF TMP SYR MIX TIPS
• D813CR00020: MTX RFL NEDLS 20GA 100BG
• D8134440040: CCD LASER SAFETY GLASSES
• D8134042010: PAINT ON DENTAL DAM SY BLU 3mL
• D8132130B0: PORC LAM POL PST 5g BAGGED
• D81321300: PORC LAM POLISH PST 5g
• D8130490181000: DIAMOND FOOTBALL INCISAL WRAP
• D8130480141000: DIAMOND EXTRA-FINE SMOOTHING
• D8130460161000: DIAMOND PORCELAIN LEDGE
• D8130460121000: CARBIDE BUR CLEAN UP
• D8130460091000: CARBIDE 12 FLUTED BUR
• D8130420161000: DIAMOND MOSQUITO INTERPROXIMAL
• D8130307991060: DISPENSING GUN 50mL 1:1/2:1
• D8130307991050: DISPENSING GUN 50mL 1:1
• D8130305942050: TIP AUTO MIX LG ORF ORG 20pc
• D8130305942010: TIPS IO WHITE 20pc
• D81300720: BRSH TIP HANDLE
• D81300710: BRSH TIP KIT 500pc (DISPOSABLE)
• D81300700: BRSH TIP/HANDLE KIT 100pc/2pc