RP Low Margin Abutment 5.0mm Cuff

GUDID 08415491020246

The RP Low Margin abutments allow for more aesthetic restorations than are possible with conventional standard abutments. Due to the abutment's conical shape, restorative components are unique to the system; yet the same restorative procedures and instrumentation are used. Available in 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm cuff sizes. They accommodate up to 25% of total divergence between implants. Small diameter allows use at mandibular anterior sites. Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491020246
• NIH Device Record Key: 35d9da8f-d547-4608-abe7-b7983b610d0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RP Low Margin Abutment 5.0mm Cuff
• Version Model Number: 904356
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• Device Count: 1
• 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: true
• 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: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08415491020246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946198

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08415491020246]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-06-02

On-Brand Devices [RP Low Margin Abutment 5.0mm Cuff]

• 08415491020246: The RP Low Margin abutments allow for more aesthetic restorations than are possible with convent
• 00841549111181: The RP Low Margin abutments allow for more aesthetic restorations than are possible with convent