SPHERO BLOCK NORMO

GUDID D821002PRI414R0

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: D821002PRI414R0
• NIH Device Record Key: fad8e8fa-bcd1-4ccc-8ac9-f1b7094b62d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPHERO BLOCK NORMO
• Version Model Number: S/BLOCK N PRIMA CONNEX ø 4,1 h.4 TiN
• 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	D821002PRI414R0 [Primary]

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

Moist Heat or Steam Sterilization

[D821002PRI414R0]

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: 2018-07-02

On-Brand Devices [SPHERO BLOCK NORMO]

• D821002XIV3R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002XIV2R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002TRE51R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002STN342R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002SPL45R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002SPL44R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002SPL42R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002SPL41R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002SMD4R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002SMD3R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002SMD1R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS51R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS505R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS434R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS433R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS432R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS431R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS4305R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS354R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS353R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002RPS352R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI54R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI53R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI52R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI51R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI414R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI413R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI412R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI411R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI353R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002PRI351R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NEO3R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NEO2R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NEO1R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC395R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC394R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC393R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC392R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC391R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC357R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC356R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC354R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC353R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC352R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC351R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC33R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC32R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002NAC31R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002LEG35R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a
• D821002LEG33R0: Titanium abutment designed as an endosseous dental implant retentive component used to retain a