DenQ Sub SLA Fixture II DSSDR50130

GUDID 08800131002629

4.9x13.0, Bone level

DenQ Co.,Ltd.

Basket endosteal dental implant, two-piece

• Primary Device ID: 08800131002629
• NIH Device Record Key: b7821d79-2e7a-4edb-a92d-a27b7c30c2dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DenQ Sub SLA Fixture II
• Version Model Number: DSSDR50130
• Catalog Number: DSSDR50130
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800131002629 [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: 2025-04-03
• Device Publish Date: 2025-03-26

On-Brand Devices [DenQ Sub SLA Fixture II]

• 08800131002223: 4.0x8.0, Bone level
• 08800131002216: 4.0x7.5, Bone level
• 08800131002209: 4.0x7.0, Bone level
• 08800131002490: 4.4x14.0, Bone level
• 08800131002483: 4.4x13.5, Bone level
• 08800131002476: 4.4x13.0, Bone level
• 08800131002469: 4.4x12.5, Bone level
• 08800131002452: 4.4x12.0, Bone level
• 08800131002445: 4.4x11.5, Bone level
• 08800131002438: 4.4x11.0, Bone level
• 08800131002421: 4.4x10.5, Bone level
• 08800131002414: 4.4x10.0, Bone level
• 08800131002407: 4.4x9.5, Bone level
• 08800131002391: 4.4x9.0, Bone level
• 08800131002384: 4.4x8.5, Bone level
• 08800131002377: 4.4x8.0, Bone level
• 08800131002360: 4.4x7.5, Bone level
• 08800131002353: 4.4x7.0, Bone level
• 08800131002346: 4.0x14.0, Bone level
• 08800131002339: 4.0x13.5, Bone level
• 08800131002322: 4.0x13.0, Bone level
• 08800131002315: 4.0x12.5, Bone level
• 08800131002308: 4.0x12.0, Bone level
• 08800131002292: 4.0x11.5, Bone level
• 08800131002285: 4.0x11.0, Bone level
• 08800131002278: 4.0x10.5, Bone level
• 08800131002261: 4.0x10.0, Bone level
• 08800131002254: 4.0x9.5, Bone level
• 08800131002247: 4.0x9.0, Bone level
• 08800131002230: 4.0x8.5, Bone level
• 08800131002643: 4.9x14.0, Bone level
• 08800131002636: 4.9x13.5, Bone level
• 08800131002629: 4.9x13.0, Bone level
• 08800131002612: 4.9x12.5, Bone level
• 08800131002605: 4.9x12.0, Bone level
• 08800131002599: 4.9x11.5, Bone level
• 08800131002582: 4.9x11.0, Bone level
• 08800131002575: 4.9x10.5, Bone level
• 08800131002568: 4.9x10.0, Bone level
• 08800131002551: 4.9x9.5, Bone level
• 08800131002544: 4.9x9.0, Bone level
• 08800131002537: 4.9x8.5, Bone level
• 08800131002520: 4.9x8.0, Bone level
• 08800131002513: 4.9x7.5, Bone level
• 08800131002506: 4.9x7.0, Bone level
• 08800131002797: 6.0x14.0, Bone level
• 08800131002780: 6.0x13.5, Bone level
• 08800131002773: 6.0x13.0, Bone level
• 08800131002766: 6.0x12.5, Bone level
• 08800131002759: 6.0x12.0, Bone level