DenQ Sub SLA Fixture I DSSR45110

GUDID 08800131000434

4.6x11.0, Bone level

DenQ Co.,Ltd.

Basket endosteal dental implant, two-piece

• Primary Device ID: 08800131000434
• NIH Device Record Key: 570b76d6-188b-4a92-a244-9cb681b47298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DenQ Sub SLA Fixture I
• Version Model Number: DSSR45110
• Catalog Number: DSSR45110
• Company DUNS: 695155534
• Company Name: DenQ Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr
• Phone: +82-7046473643
• Email: s@denq.co.kr

Operating and Storage Conditions

• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800131000434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240977

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-15
• Device Publish Date: 2025-01-07

On-Brand Devices [DenQ Sub SLA Fixture I]

• 08800131000021: 3.7x7.5, Bone level
• 08800131000014: 3.7x7, Bone level
• 08800131000083: 3.7x10.5, Bone level
• 08800131000076: 3.7x10.0, Bone level
• 08800131000069: 3.7x9.5, Bone level
• 08800131000052: 3.7x9, Bone level
• 08800131000045: 3.7x8.5, Bone level
• 08800131000038: 3.7x8, Bone level
• 08800131000724: 5.95x8.5, Bone level
• 08800131000717: 5.95x8.0, Bone level
• 08800131000700: 5.95x7.5, Bone level
• 08800131000694: 5.95x7.0, Bone level
• 08800131000687: 5.1x15.0, Bone level
• 08800131000670: 5.1x14.5, Bone level
• 08800131000663: 5.1x14.0, Bone level
• 08800131000656: 5.1x13.5, Bone level
• 08800131000649: 5.1x13.0, Bone level
• 08800131000632: 5.1x12.5, Bone level
• 08800131000625: 5.1x12.0, Bone level
• 08800131000618: 5.1x11.5, Bone level
• 08800131000601: 5.1x11.0, Bone level
• 08800131000595: 5.1x10.5, Bone level
• 08800131000588: 5.1x10.0, Bone level
• 08800131000571: 5.1x9.5, Bone level
• 08800131000564: 5.1x9.0, Bone level
• 08800131000557: 5.1x8.5, Bone level
• 08800131000540: 5.1x8.0, Bone level
• 08800131000533: 5.1x7.5, Bone level
• 08800131000526: 5.1x7.0, Bone level
• 08800131000519: 4.6x15.0, Bone level
• 08800131000502: 4.6x14.5, Bone level
• 08800131000496: 4.6x14.0, Bone level
• 08800131000489: 4.6x13.5, Bone level
• 08800131000472: 4.6x13.0, Bone level
• 08800131000465: 4.6x12.5, Bone level
• 08800131000458: 4.6x12.0, Bone level
• 08800131000441: 4.6x11.5, Bone level
• 08800131000434: 4.6x11.0, Bone level
• 08800131000427: 4.6x10.5, Bone level
• 08800131000410: 4.6x10.0, Bone level
• 08800131000403: 4.6x9.5, Bone level
• 08800131000397: 4.6x9.0, Bone level
• 08800131000380: 4.6x8.5, Bone level
• 08800131000373: 4.6x8.0, Bone level
• 08800131000366: 4.6x7.5, Bone level
• 08800131000359: 4.6x7.0, Bone level
• 08800131000342: 4.2x15.0, Bone level
• 08800131000335: 4.2x14.5, Bone level
• 08800131000328: 4.2x14.0, Bone level
• 08800131000311: 4.2x13.5, Bone level