DenQ Sub SLA Fixture III DSS3R40080

GUDID 08800131004029

4.2x8.0, Bone level

DenQ Co.,Ltd.

Basket endosteal dental implant, two-piece

• Primary Device ID: 08800131004029
• NIH Device Record Key: bee55a9d-08f1-4396-afed-16c11a32b5a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DenQ Sub SLA Fixture III
• Version Model Number: DSS3R40080
• Catalog Number: DSS3R40080
• 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
• 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
• 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	08800131004029 [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: 2025-04-07
• Device Publish Date: 2025-03-28

On-Brand Devices [DenQ Sub SLA Fixture III]

• 08800131004210: 4.6x10.0, Bone level
• 08800131004203: 4.6x9.5, Bone level
• 08800131004197: 4.6x9.0, Bone level
• 08800131004180: 4.6x8.5, Bone level
• 08800131004173: 4.6x8.0, Bone level
• 08800131004166: 4.6x7.5, Bone level
• 08800131004159: 4.6x7.0, Bone level
• 08800131004142: 4.2x14.0, Bone level
• 08800131004135: 4.2x13.5, Bone level
• 08800131004128: 4.2x13.0, Bone level
• 08800131004111: 4.2x12.5, Bone level
• 08800131004104: 4.2x12.0, Bone level
• 08800131004098: 4.2x11.5, Bone level
• 08800131004081: 4.2x11.0, Bone level
• 08800131004074: 4.2x10.5, Bone level
• 08800131004067: 4.2x10.0, Bone level
• 08800131004050: 4.2x9.5, Bone level
• 08800131004043: 4.2x9.0, Bone level
• 08800131004036: 4.2x8.5, Bone level
• 08800131004029: 4.2x8.0, Bone level
• 08800131004012: 4.2x7.5, Bone level
• 08800131004005: 4.2x7.0, Bone level
• 08800131004746: 6.8x14.0, Bone level
• 08800131004739: 6.8x13.5, Bone level
• 08800131004722: 6.8x13.0, Bone level
• 08800131004715: 6.8x12.5, Bone level
• 08800131004708: 6.8x12.0, Bone level
• 08800131004692: 6.8x11.5, Bone level
• 08800131004685: 6.8x11.0, Bone level
• 08800131004678: 6.8x10.5, Bone level
• 08800131004661: 6.8x10.0, Bone level
• 08800131004654: 6.8x9.5, Bone level
• 08800131004647: 6.8x9.0, Bone level
• 08800131004630: 6.8x8.5, Bone level
• 08800131004623: 6.8x8.0, Bone level
• 08800131004616: 6.8x7.5, Bone level
• 08800131004609: 6.8x7.0, Bone level
• 08800131004593: 5.95x14.0, Bone level
• 08800131004586: 5.95x13.5, Bone level
• 08800131004579: 5.95x13.0, Bone level
• 08800131004562: 5.95x12.5, Bone level
• 08800131004555: 5.95x12.0, Bone level
• 08800131004548: 5.95x11.5, Bone level
• 08800131004531: 5.95x11.0, Bone level
• 08800131004524: 5.95x10.5, Bone level
• 08800131004517: 5.95x10.0, Bone level
• 08800131004500: 5.95x9.5, Bone level
• 08800131004494: 5.95x9.0, Bone level
• 08800131004487: 5.95x8.5, Bone level
• 08800131004470: 5.95x8.0, Bone level