SQ-SL AXEL Fixture

GUDID 08800313233957

SQ-SL AXEL Fixture (DSAFM4218S)

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800313233957
• NIH Device Record Key: 40b68ef2-008d-4e2a-9546-b87ad386c693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SQ-SL AXEL Fixture
• Version Model Number: DSAFM4218S
• Company DUNS: 694721181
• Company Name: DENTIS CO. ,LTD
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800313233957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253493

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: 2026-03-17
• Device Publish Date: 2026-03-09

On-Brand Devices [SQ-SL AXEL Fixture]

• 08800313234039: SQ-SL AXEL Fixture (DSAFR5018XS)
• 08800313234022: SQ-SL AXEL Fixture (DSAFR5016XS)
• 08800313234015: SQ-SL AXEL Fixture (DSAFR5018S)
• 08800313234008: SQ-SL AXEL Fixture (DSAFR5016S)
• 08800313233995: SQ-SL AXEL Fixture (DSAFR4618S)
• 08800313233988: SQ-SL AXEL Fixture (DSAFR4616S)
• 08800313233971: SQ-SL AXEL Fixture (DSAFR4218S)
• 08800313233964: SQ-SL AXEL Fixture (DSAFR4216S)
• 08800313233957: SQ-SL AXEL Fixture (DSAFM4218S)
• 08800313233940: SQ-SL AXEL Fixture (DSAFM4216S)
• 08800313233933: SQ-SL AXEL Fixture (DSAFM3818S)
• 08800313233926: SQ-SL AXEL Fixture (DSAFM3816S)
• 08800313233919: SQ-SL AXEL Fixture (DSAFR5018X)
• 08800313233902: SQ-SL AXEL Fixture (DSAFR5016X)
• 08800313233896: SQ-SL AXEL Fixture (DSAFR5018)
• 08800313233889: SQ-SL AXEL Fixture (DSAFR5016)
• 08800313233872: SQ-SL AXEL Fixture (DSAFR4618)
• 08800313233865: SQ-SL AXEL Fixture (DSAFR4616)
• 08800313233858: SQ-SL AXEL Fixture (DSAFR4218)
• 08800313233841: SQ-SL AXEL Fixture (DSAFR4216)
• 08800313233834: SQ-SL AXEL Fixture (DSAFM4218)
• 08800313233827: SQ-SL AXEL Fixture (DSAFM4216)
• 08800313233810: SQ-SL AXEL Fixture (DSAFM3818)
• 08800313233803: SQ-SL AXEL Fixture (DSAFM3816)
• 08800313231984: SQ-SL AXEL Fixture (DSAFW7012XS)
• 08800313231977: SQ-SL AXEL Fixture (DSAFW7010XS)
• 08800313231960: SQ-SL AXEL Fixture (DSAFW7009XS)
• 08800313231953: SQ-SL AXEL Fixture (DSAFW7008XS)
• 08800313231946: SQ-SL AXEL Fixture (DSAFW7007XS)
• 08800313231939: SQ-SL AXEL Fixture (DSAFW6012XS)
• 08800313231922: SQ-SL AXEL Fixture (DSAFW6010XS)
• 08800313231915: SQ-SL AXEL Fixture (DSAFW6009XS)
• 08800313231908: SQ-SL AXEL Fixture (DSAFW6008XS)
• 08800313231892: SQ-SL AXEL Fixture (DSAFW6007XS)
• 08800313231885: SQ-SL AXEL Fixture (DSAFR5414XS)
• 08800313231878: SQ-SL AXEL Fixture (DSAFR5412XS)
• 08800313231861: SQ-SL AXEL Fixture (DSAFR5410XS)
• 08800313231854: SQ-SL AXEL Fixture (DSAFR5409XS)
• 08800313231847: SQ-SL AXEL Fixture (DSAFR5408XS)
• 08800313231830: SQ-SL AXEL Fixture (DSAFR5407XS)
• 08800313231823: SQ-SL AXEL Fixture (DSAFR5014XS)
• 08800313231816: SQ-SL AXEL Fixture (DSAFR5012XS)
• 08800313231809: SQ-SL AXEL Fixture (DSAFR5010XS)
• 08800313231793: SQ-SL AXEL Fixture (DSAFR5009XS)
• 08800313231786: SQ-SL AXEL Fixture (DSAFR5008XS)
• 08800313231779: SQ-SL AXEL Fixture (DSAFR5007XS)
• 08800313231762: SQ-SL AXEL Fixture (DSAFR5414S)
• 08800313231755: SQ-SL AXEL Fixture (DSAFR5412S)
• 08800313231748: SQ-SL AXEL Fixture (DSAFR5410S)
• 08800313231731: SQ-SL AXEL Fixture (DSAFR5409S)