TRI-TAPERED 1312165

GUDID 00614950015085

RP UCLA Abutment, Non-Engaging, D 5.5 mm

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece

• Primary Device ID: 00614950015085
• NIH Device Record Key: eaea9814-96cb-483b-95d7-e7fc31d06c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRI-TAPERED
• Version Model Number: 1312165
• Catalog Number: 1312165
• 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: false
• 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

• Height: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950015085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103790

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

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: 2019-03-11
• Device Publish Date: 2019-02-12

On-Brand Devices [TRI-TAPERED]

• 00614950014637: TRI-TAPERED RP Implant, Ø 4.3 mm/4.3 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950014620: TRI-TAPERED RP Implant, Ø 4.3 mm/4.3 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950016358: TRI-TAPERED NP Implant, Ø 3.5 mm/3.5 mm, L 8.0 mm; incl. Sterile Cover Screw
• 00614950016341: TRI-TAPERED NP Implant, Ø 3.5 mm/3.5 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950016297: TRI-TAPERED NP Implant, Ø 3.5 mm/3.5 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950016051: TRI-TAPERED RP Implant, Ø 4.3 mm/4.3 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950015931: TRI-TAPERED NP Implant, Ø 4.3 mm/3.5 mm, L 16.0 mm; incl. Sterile Cover Screw
• 00614950015924: TRI-TAPERED NP Implant, Ø 4.3 mm/3.5 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950015429: TRI-TAPERED NP Implant, Ø 4.3 mm/3.5 mm, L 8.0 mm; incl. Sterile Cover Screw
• 00614950015412: TRI-TAPERED NP Implant, Ø 3.5 mm/3.5 mm, L 16.0 mm; incl. Sterile Cover Screw
• 00614950015405: TRI-TAPERED NP Implant, Ø 3.5 mm/3.5 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950014996: TRI-TAPERED RP Implant, Ø 4.3 mm/4.3 mm, L 8.0 mm; incl. Sterile Cover Screw
• 00614950014989: TRI-TAPERED NP Implant, Ø 4.3 mm/3.5 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950014972: TRI-TAPERED NP Implant, Ø 4.3 mm/3.5 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950014965: TRI-TAPERED RP Implant, Ø 5.0 mm/4.3 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950014958: TRI-TAPERED RP Implant, Ø 5.0 mm/4.3 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950014941: TRI-TAPERED RP Implant, Ø 5.0 mm/4.3 mm, L 8.0 mm; incl. Sterile Cover Screw
• 00614950014934: TRI-TAPERED RP Implant, Ø 4.3mm/4.3 mm, L 16.0 mm; incl. Sterile Cover Screw
• 00614950014927: TRI-TAPERED RP Implant, Ø 4.3 mm/4.3 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950014910: TRI-TAPERED RP Implant, Ø 4.3 mm/4.3 mm, L 11.5 mm; incl. Sterile Cover Screw
• 00614950014750: TRI-TAPERED WP Implant, Ø 5.0 mm/5.0 mm, L 16.0 mm; incl. Sterile Cover Screw
• 00614950014743: TRI-TAPERED WP Implant, Ø 5.0 mm/5.0 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950014729: TRI-TAPERED WP Implant, Ø 5.0 mm/5.0 mm, L 10.0 mm; incl. Sterile Cover Screw
• 00614950014699: TRI-TAPERED RP Implant, Ø 5.0 mm/4.3 mm, L 13.0 mm; incl. Sterile Cover Screw
• 00614950015115: WP UCLA Abutment, Engaging, D 6.0 mm
• 00614950015108: WP UCLA Abutment, Non-Engaging, D 6.0 mm
• 00614950015092: RP UCLA Abutment, Engaging, D 5.5 mm
• 00614950015085: RP UCLA Abutment, Non-Engaging, D 5.5 mm
• 00614950015078: NP UCLA Abutment, Engaging, D 4.5 mm
• 00614950015061: NP UCLA Abutment, Non-Engaging, D 4.5 mm
• 00614950015054: WP Titanium Prepable Abutment, GH 4 mm, D 6.0 mm, AH 5.0 mm
• 00614950015047: WP Titanium Prepable Abutment, GH 2 mm, D 6.0 mm, AH 5.0 mm
• 00614950015030: RP Titanium Prepable Abutment, GH 4 mm, D 5.5 mm, AH 5.0 mm
• 00614950015023: RP Titanium Prepable Abutment, GH 2 mm, D 5.5 mm, AH 5.0 mm
• 00614950015016: NP Titanium Prepable Abutment, GH 4 mm, D 4.5 mm, AH 5.0 mm
• 00614950015009: NP Titanium Prepable Abutment, GH 2 mm, D 4.5 mm, AH 5.0 mm
• 00614950014903: WP Straight Healing Abutment, D 5.0 mm, H 5.0 mm
• 00614950014897: WP Straight Healing Abutment, D 5.0 mm, H 3.0 mm
• 00614950014880: RP Straight Healing Abutment, D 4.3 mm, H 5.0 mm
• 00614950014873: RP Straight Healing Abutment, D 4.3 mm, H 3.0 mm
• 00614950014866: NP Straight Healing Abutment, D 3.5 mm, H 5.0 mm
• 00614950014859: NP Straight Healing Abutment, D 3.5 mm, H 3.0 mm
• 00614950014842: WP Contoured Healing Abutment, D 6.0 mm, H 5.0 mm
• 00614950014835: WP Contoured Healing Abutment, D 6.0 mm, H 3.0 mm
• 00614950014828: RP Contoured Healing Abutment, D 5.5 mm, H 5.0 mm
• 00614950014811: RP Contoured Healing Abutment, D 5.5 mm, H 3.0 mm
• 00614950014804: NP Contoured Healing Abutment, D 4.5 mm, H 5.0 mm
• 00614950014798: NP Contoured Healing Abutment, D 4.5 mm, H 3.0 mm