Keles Keyless Expander

GUDID 00860013171711

KKE-Keles Keyless Expander 8mm without Legs

Aegis Star Dental Technologies Inc.

Orthodontic palate expander screw, self-removable

• Primary Device ID: 00860013171711
• NIH Device Record Key: 716ad561-756e-41d4-a8b3-32f2b3bc1a5f
• Commercial Distribution Discontinuation: 2024-12-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Keles Keyless Expander
• Version Model Number: KKE1-08NL
• Company DUNS: 119341607
• Company Name: Aegis Star Dental Technologies Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013171711 [Primary]

FDA Product Code

• DYJ: Retainer, Screw Expansion, Orthodontic

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: 2024-12-17
• Device Publish Date: 2024-12-09

On-Brand Devices [Keles Keyless Expander]

• 00860013171759: KKE-Keles Keyless Expander 12mm without Legs
• 00860013171742: KKE-Keles Keyless Expander 12mm with Legs
• 00860013171735: KKE-Keles Keyless Expander 10mm without Legs
• 00860013171728: KKE-Keles Keyless Expander 10mm with Legs
• 00860013171711: KKE-Keles Keyless Expander 8mm without Legs
• 00860013171704: KKE-Keles Keyless Expander 8mm with Legs