Essix ACE 1A320

GUDID D7461A3201

Essix ACE 030 x 120mm PCTG Vacuum Circle 100pk

RAINTREE ESSIX INC.

Dental implant template, radiographic

• Primary Device ID: D7461A3201
• NIH Device Record Key: a3ae92b2-938f-48be-bf17-10a070836757
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Essix ACE
• Version Model Number: 1A320
• Catalog Number: 1A320
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 100
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7461A3200 [Unit of Use]
HIBCC	D7461A3201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062828

FDA Product Code

• NXC: Aligner, sequential

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Essix ACE]

• D74625325301: ESSIX ACE (BX/100) RM008 (SAME AS RAINTREE PART 1A420)
• D7461A4781: Essix ACE 040 x 4.875" PCTG Vacuum Square 100pk
• D7461A450SH1: Essix ACE 040 x 5" PCTG Vacuum Square 20PK
• D7461A450501: Essix ACE .040 x 5" PCTG Square 50pk
• D7461A4501: Essix ACE 040 x 5" x 5" PCTG Vacuum Square 100pk
• D7461A425SH1: Essix ACE 040 x 125mm PCTG Vacuum Circle 20pk
• D7461A425501: Essix ACE .040 x 125mm PCTG Circle 50pk
• D7461A4251: Essix ACE 040 x 125mm PCTG Vacuum Circle 100pk
• D7461A420501: Essix ACE .040 x 120mm PCTG Circle 50pk
• D7461A4201: Essix ACE 040 x 120mm PCTG Vacuum Circle 100pk
• D7461A350SH1: Essix ACE 030 x 5" PCTG Vacuum Square 20PK
• D7461A350501: Essix ACE .030 x 5" PCTG Square 50pk
• D7461A3501: Essix ACE 030 x 5" PCTG Vacuum Square 100pk
• D7461A347501: Essix ACE .030 x 125mm Square 50pk
• D7461A3471: Essix ACE 030 x 125mm Square 100/PK
• D7461A325SH1: Essix ACE 030 x 125mm PCTG Vacuum Circle 20PK
• D7461A325501: Essix ACE .030 x 125mm PCTG Circle 50pk
• D7461A3251: Essix ACE 030 x 125mm PCTG Vacuum Circle 100pk
• D7461A320501: Essix ACE .030 x 120mm PCTG Circle 50pk
• D7461A3201: Essix ACE 030 x 120mm PCTG Vacuum Circle 100pk