Hexagon 1312071

GUDID 00614950015795

RP Cover Screw, D 4.5 mm, H 0 mm

ACE SURGICAL SUPPLY CO., INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00614950015795
• NIH Device Record Key: 065616b2-e9a0-40a1-bdfc-7fc9467903f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hexagon
• Version Model Number: 1312071
• Catalog Number: 1312071
• Company DUNS: 042763706
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com

Device Dimensions

• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950015795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102981

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-02-12

On-Brand Devices [Hexagon]

• 00614950016037: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950015795: RP Cover Screw, D 4.5 mm, H 0 mm
• 00614950015788: NP Cover Screw, D 3.5 mm, H 0 mm
• 00614950015771: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 16.0 mm; incl. Sterile Cover Screw
• 00614950015764: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950015757: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950015740: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950015733: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 8.0 mm; incl. Sterile Cover Screw
• 00614950015726: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 6.0 mm; incl. Sterile Cover Screw
• 00614950015719: HEXAGON RP Implant, Ø 4.7 mm/4.5 mm, L 16.0 mm; incl. Sterile Cover Screw
• 00614950015702: HEXAGON RP Implant, Ø 4.7 mm/4.5 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950015696: HEXAGON RP Implant, Ø 4.7 mm/4.5 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950015689: HEXAGON RP Implant, Ø 4.7 mm/4.5 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950015672: HEXAGON RP Implant, Ø 4.7 mm/4.5 mm, L 8.0 mm; incl. Sterile Cover Screw
• 00614950015665: HEXAGON NP Implant, Ø 4.7 mm/3.5 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950015658: HEXAGON NP Implant, Ø 4.7 mm/3.5 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950015641: HEXAGON NP Implant, Ø 4.7 mm/3.5 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950015634: HEXAGON NP Implant, Ø 4.7 mm/3.5 mm, L 8.0 mm; incl. Sterile Cover Screw
• 00614950015627: HEXAGON NP Implant, Ø 4.1 mm/3.5 mm, L 16.0 mm; incl. Sterile Cover Screw
• 00614950015610: HEXAGON NP Implant, Ø 4.1 mm/3.5 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950015603: HEXAGON NP Implant, Ø 4.1 mm/3.5 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950015597: HEXAGON NP Implant, Ø 4.1 mm/3.5 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950015580: HEXAGON NP Implant, Ø 4.1 mm/3.5 mm, L 8.0 mm; incl. Sterile Cover Screw
• 00614950015573: HEXAGON NP Implant, Ø 4.1 mm/3.5 mm, L 6.0 mm; incl. Sterile Cover Screw
• 00614950015566: HEXAGON NP Implant, Ø 3.7 mm/3.5 mm, L 16.0 mm; incl. Sterile Cover Screw
• 00614950015559: HEXAGON NP Implant, Ø 3.7 mm/3.5 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950015542: HEXAGON NP Implant, Ø 3.7 mm/3.5 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950015535: HEXAGON NP Implant, Ø 3.7 mm/3.5 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950015528: HEXAGON NP Implant, Ø 3.7 mm/3.5 mm, L 8.0 mm; incl. Sterile Cover Screw
• 00614950015504: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 16.0 mm; incl. Sterile Cover Screw
• 00614950015481: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950015139: HEXAGON RP Implant, Ø 5.1 mm/4.5 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950014781: WP Cover Screw, D 5.0 mm, H 0 mm
• 00614950014774: RP Cover Screw, D 4.3 mm, H 0 mm
• 00614950014767: NP Cover Screw, D 3.5 mm, H 0 mm
• 00614950025732: COLLAGEN BLOCK 10X11X12 500MG
• 00614950025725: COLLAGEN BLOCK 8X9X9MM 250MG
• 00614950025718: COLLAGEN BLOCK 6X7X8MM 100MG
• 00614950016013: RP UCLA Abutment, Engaging, D 5.5 mm
• 00614950016006: RP UCLA Abutment, Non-Engaging, D 5.5 mm
• 00614950015993: NP UCLA Abutment, Engaging, D 4.5 mm
• 00614950015986: NP UCLA Abutment, Non-Engaging, D 4.5 mm
• 00614950015979: RP Titanium Prepable Abutment, GH 4.0 mm, D 5.5 mm, AH 5.0 mm
• 00614950015962: RP Titanium Prepable Abutment, GH 2.0 mm, D 5.5 mm, AH 5.0 mm
• 00614950015955: NP Titanium Prepable Abutment, GH 4.0 mm, D 4.5 mm, AH 5.0 mm
• 00614950015948: NP Titanium Prepable Abutment, GH 2.0 mm, D 4.5 mm, AH 5.0 mm
• 00614950015917: RP Straight Healing Abutment, D 4.7 mm, H 5.0 mm
• 00614950015900: RP Straight Healing Abutment, D 4.7 mm, H 3.0 mm
• 00614950015894: NP Straight Healing Abutment, D 3.7 mm, H 5.0 mm
• 00614950015887: NP Straight Healing Abutment, D 3.7 mm, H 3.0 mm