SPHERO FLEX

GUDID D821109NAC394R0

Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.

RHEIN 83 SRL

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D821109NAC394R0
• NIH Device Record Key: d1008e90-f532-4d21-9026-2c4fd30134d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPHERO FLEX
• Version Model Number: S/FLEX NOBEL ACTIVE RP ø 4,3/5 h.4
• Company DUNS: 439240722
• Company Name: RHEIN 83 SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D821109NAC394R0 [Primary]

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

[D821109NAC394R0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-07-04

On-Brand Devices [SPHERO FLEX]

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• D821109SPL3252R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109RPS52R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109RPS435R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109RPS434R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109RPS433R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109RPS432R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109RPS431R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109RPS352R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109PRI414R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109PRI413R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109PRI411R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109NAC394R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109NAC392R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109NAC353R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109NAC352R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109NAC351R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109IIC54R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109IIC45R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109IIC44R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109IIC43R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109IIC42R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109IIC41R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109IIC405R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109ENI432R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109CV7RT0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109CV5R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109CV4R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109CV3R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109CV2R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109CV1R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109CLK42R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BV454R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BV453R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BV452R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BV451R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BRKWP53R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BRK4R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BRK3R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BRK2R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BRK1R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BFTR0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109BFT3R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109AS4NC4R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109AS4NC3R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109AOL2R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109AOA4R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821109AOA3R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a