Rodo Abutment Accessories 40.103

GUDID 00816131021902

Abutment Screws for Neodent: CM Multi-Unit 17º, 30º Abutments and Neodent CM Wide Abutments - All Gingival Heights

RODO MEDICAL, INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00816131021902
• NIH Device Record Key: 28fa2eee-f9ba-4a14-9201-a023ae77293b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rodo Abutment Accessories
• Version Model Number: 40.103
• Catalog Number: 40.103
• Company DUNS: 004584361
• Company Name: RODO MEDICAL, INC.
• Device Count: 10
• 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: 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(408)245-7636
• Email: info@rodomedical.com
• Phone: +1(408)245-7636
• Email: info@rodomedical.com
• Phone: +1(408)245-7636
• Email: info@rodomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816131021902 [Primary]
GS1	10816131021909 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160786

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-12-07

On-Brand Devices [Rodo Abutment Accessories]

• 00816131021957: M2.0 x 0.40 x 7.3 mm Abutment Screws
• 00816131021940: M1.8 x 0.35 x 5.4 mm Abutment Screws
• 00816131021933: Abutment Screws for Nobel: IC, RP & WP Multi-Unit 17º, 30º Abutments and Nobel IC, RP & WP Wid
• 00816131021926: M1.6 x 0.35 x 5.2 mm Abutment Screws
• 00816131021919: M2.0 x 0.40 x 7.9 mm Abutment Screws
• 00816131021902: Abutment Screws for Neodent: CM Multi-Unit 17º, 30º Abutments and Neodent CM Wide Abutments -
• 00816131021896: Abutment Screws for Straumann: BL, RC & NC Multi-Unit 17º, 30º Abutments and Straumann BL RC W
• 00816131021742: D-Smileloc 0