Sphero Block Normo

489 catalogue numbers from S/BLOCK NORMO CERTAIN 3I ø 4,1 h.4 TiN, listed by Rhein 83 SRL, Italy, under Implant, Endosseous, Root-Form. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
489catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZE
Manufacturer City Province Registered as Device types
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Jiangsu Trausim Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 3
Basic (Chengdu) Medical Device Co., Ltd. Chengdu Sichuan Contract manufacturer 1
Dongguan Xinlonghong Hardware Co., Ltd. Dongguan Guangdong Contract manufacturer 1
Chengdu Besmile Medical Technology Co., Ltd. Chengdu Sichuan Manufacturer 14
BIO Concept Co., Ltd. Changzhou Jiangsu Manufacturer 5

Record

Regulatory record for Sphero Block Normo
Listed by Rhein 83 SRL, Italy
FDA product code DZE
Device type Implant, Endosseous, Root-Form
Device class Class 2
Regulation 21 CFR 872.3640
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
Record published 2018-07-02
Record revised 2020-12-17 (version 4)

Specifications

Specifications
MRI safety MR Unsafe
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, manufacturing date, serial number
Distribution end date 2021-07-23

Catalogue Numbers

Catalogue numbers for Sphero Block Normo
Catalogue number Size Status
S/BLOCK NORMO CERTAIN 3I ø 4,1 h.4 TiN In distribution
S/BLOCK N PRIMA CONNEX ø 3,5 h.3 TiN In distribution
S/BLOCK N ASTRA ACQUA ø3,5-4 h.3 TiN In distribution
S/BLOCK N BIO HORIZONS ø 3 h.5 TiN In distribution
S/BLOCK N BONE LEVEL RC ø4,1-4,8 h.1 TiN In distribution
SPHERO BLOCK NORMO BRANEMARK h.5 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 4,1 h.1 TiN In distribution
S/BLOCK NORMO IMTEC MINI ø 3,3 h.5 TiN In distribution
S/BLOCK N NOBEL ACTIVE NP ø 3,5 h.1 TiN In distribution
S/BLOCK M ASTRA EV ø 5,4 h.5 In distribution
S/BLOCK NORMO LEGACY ø 3 h.1 TiN In distribution
SPHERO BLOCK NORMO BRANEMARK h.3 TiN In distribution
SPHERO BLOCK NORMO STRAUMANN ITI h.5 TiN In distribution
S/BLOCK NORMO SPLINE ø 3,75-4 h.4 TiN In distribution
SPHERO BLOCK NORMO STRAUMANN ITI h.4 TiN In distribution
SET S.BLOCK N. IBS MAGICORE ø4 h4 In distribution
SET S.BLOCK N. IBS MAGICORE ø 4 h5 In distribution
SPHERO BLOCK NORMO STRAUMANN h.2 TiN In distribution
S/BLOCK N BIO HORIZONS ø 3 h.4 TiN In distribution
SET S.BLOCK N.IBS MAGICORE ø5 h3 In distribution
S/BLOCK NORMO ASTRA ø 3 h.0,7 TiN In distribution
S/BLOCK M INTEGR/OMNIL. ø 3,25 h.1 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 4,1 h.3 TiN In distribution
S/BLOCK N CONELOG ø 4,3 h.5 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 5 h.4 TiN In distribution
S/B/M BONE LEVEL RC ø 4,1/4,8 h 5 TiN In distribution
S/BLOCK N NOBEL ACTIVE NP ø S/BLOCK N NOBEL ACTIVE NP ø 3 h.3 TiNh.2 TiN In distribution
SPHERO BLOCK N SCREW VENT h.2 TiN In distribution
SPHERO BLOCK N/BIO HORIZONS ø 4 h.2 TiN In distribution
S/BLOCK NORMO BIO VENT ø 4,5 h.4 TiN In distribution
S/BLOCK N ASTRA LILLA ø 4,5-5 h.4 TiN In distribution
SPHERO B/MICRO INTEG/OMN. 3.25 h.5 TiN In distribution
S. BLOCK N. MEGAGEN BLUE DIAMOND RC h3 In distribution
SPHERO BLOCK N SCREW VENT h.2 TiN In distribution
SPHERO BLOCK NORMO STRAUMANN ITI h.6 TiN In distribution
S/BLOCK NORMO SCREW VENT ø 5,7 h.4 TiN In distribution
SPHERO BLOCK N BRANEMARK h.1,3 TiN In distribution
S/BLOCK NOBEL ACTIVE RP ø 4,3/5 h.2 TiN In distribution
S/BLOCK N ASTRA ST ø 4 h.5 TiN In distribution
S/BLOCK NORMO BIO VENT ø 4.5 h.5 TiN In distribution
S/BLOCK N NOBEL ACTIVE NP ø 3,5 h.7 TiN In distribution
S/BLOCK N BIO HORIZONS ø 3,5 h.3 TiN In distribution
S/BLOCK N ASTRA ST ø 4 h.7 TiN In distribution
S/BLOCK N NOBEL ACTIVE NP ø 3,5 h.6 TiN In distribution
SPHERO BLOCK MICRO CAMLOG ø 3,8 h.1 TiN In distribution
SPHERO BLOCK Micro CORE VENT h.7 RIV.TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 5 h.1 TiN In distribution
S/BLOCK N NOBEL ACTIVE NP ø 3,5 h.4 TiN In distribution
S/BLOCK N GSII Mini ø 3,5 h.3 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 5 h.2 TiN In distribution
S/BLOCK NORMO CORE VENT h.4 TiN c/TAS In distribution
S/BLOCK N MIS – SEVEN h.4 TiN In distribution
S/BLOCK NORMO SPLINE ø 3,75-4 h.2 TiN In distribution
SPHERO BLOCK NORMO BRANEMARK h.4 TiN In distribution
SET S.BLOCK N. REPL SELECT ø 4.3 h7 In distribution
S/BLOCK N ASTRA ACQUA ø3,5-4 h.6 TiN In distribution
SPHERO BLOCK N ASTRA EV ø 4,8 h.4 In distribution
S/BLOCK N ASTRA LILLA ø 4,5-5 h.5 TiN In distribution
SET S.BLOCK N.IBS MEDICORE ø5 h5 In distribution
SPHERO BLOCK NORMO EZTETIC ø 3,1 h.4 In distribution
S/BLOCK N ASTRA ACQUA ø3,5-4 h.2 TiN In distribution
SPHERO BLOCK N CAMLOG ø 3,3 h.3 RIV.TiN In distribution
SPHERO BLOCK N SCREW VENT h.4 TiN In distribution
SPHERO BLOCK N/BIO HORIZONS ø 4 h.7 TiN In distribution
S/BLOCK NORMO LEGACY ø 3 h.3 TiN In distribution
SPHERO BLOCK N/BIO HORIZONS ø 4 h.3 TiN In distribution
SPHERO B/MICRO INTEGRAL ø 4 h.3 TiN In distribution
S/BLOCK M ASTRA EV ø 4,2 h.1 TIN In distribution
SPHERO BLOCK NORMO ASTRA EV ø 3 h.6 Tin In distribution
S/BLOCK N BIO HORIZONS ø 3,5 h.6 TiN In distribution
S. BLOCK N. MEGAGEN BLUE DIAMOND RC h2 In distribution
S/BLOCK N PRIMA CONNEX ø 4,1 h.1 TiN In distribution
S/BLOCK NORMO BRK/Restore WP ø 5 h.4 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 5 h.3 TiN In distribution
S/BLOCK N ASTRA LILLA ø 4,5-5 h.7 TiN In distribution
S/BLOCK N BIO HORIZONS ø 3,5 h.2 TiN In distribution
S.BLOCK N. MIS SEVEN ø 3.3 NP h3 In distribution
S/BLOCK N GSII Mini ø 3,5 h.2 TiN In distribution
SET S.BLOCK N. SCREW VENT h6 -TE In distribution
S/BLOCK N CERTAIN 3I ø 3,4 h.0,5 TiN In distribution
S/BLOCK NORMO BRK/Restore WP ø 5 h.3 TiN In distribution
SET S.BLOCK N. MIS SEVEN ø 3.75-4.2 h2 In distribution
S/BLOCK N PRIMA CONNEX ø 4,1 h.3 TiN In distribution
S/BLOCK N PRIMA CONNEX ø 4,1 h.4 TiN In distribution
SPHERO BLOCK ANKYLOS C/X h.6 In distribution
SPHERO BLOCK Micro REPLACE ø 4,3 h.1 TiN In distribution
SPHERO BLOCK NORMO IMZ ø 3,3 h.7 TiN In distribution
SPHERO B/MICRO INTEGRAL ø 4 h.5 TiN In distribution
SET S.BLOCK N. BIOVENT ø 4.5 h6 -TE In distribution
S/BLOCK NORMO SCREW VENT ø 5,7 h.1TiN In distribution
S/BLOCK N PRIMA CONNEX ø 5 h.2 TiN In distribution
SET S.BLOCK N. IBS Magicore ø 5 h1 In distribution
SPHERO BLOCK NORMO NEO h.2 TiN In distribution
SPHERO BLOCK NORMO STRAUMANN ITI h.1 TiN In distribution
S/BLOCK N. C1 Std MIS ø 3,75-4,2 h.2 In distribution
S.BLOCK N. C1 Narrow MIS ø 3,3 h.6 TiN In distribution
S/BLOCK N BONE LEVEL RC ø4,1-4,8 h.2 TiN In distribution
SPHERO BLOCK N/BIO HORIZONS ø 4 h.1,5 TiN In distribution
S/BLOCK N BONE LEVEL RC ø4,1-4,8 h.3 TiN In distribution
S/ BLOCK NORMO REPL/SELECT ø 5 h.2 TiN In distribution
S/BLOCK M. BONE LEVEL SC ø 2,9 h.3 TiN In distribution
SPHERO BLOCK M ANYRIDGE h.7 TiN In distribution
S/BLOCK N ASTRA ST ø 4 h.6 TiN In distribution
S.BLOCK N. REPL/SELECT ø 3,5 h.1 TiN In distribution
SPHERO BLOCK NORMO IMZ ø 3,3 h.4 TiN In distribution
S/BLOCK N BONE LEVEL RC ø4,1-4,8 h.5 TiN In distribution
S/BLOCK N GSII Mini ø 3,5 h.4 TiN In distribution
SET S.BLOCK N. BLX RB-WB h3 In distribution
SET S.BLOCK N. IBS MAGICORE ø 4 h05 In distribution
S/BLOCK NORMO ASTRA ø 3 h.2 TiN In distribution
SET S.BLOCK N. IBS MAGICORE ø 4 h2 In distribution
S/BLOCK N STERI OSS ø 3,25 h.2 TiN In distribution
S/BLOCK M NOBEL ACTIVE ø 3 h.2 TiN In distribution
SPHERO BLOCK NORMO IMZ ø 4 h.2 TiN In distribution
S/BLOCK Micro STERI OSS ø 3,25 h.3 TiN In distribution
SPHERO BLOCK N/BIO HORIZONS ø 4 h.6 TiN In distribution
SPHERO BLOCK MICRO CAMLOG ø 3,8 h.3 TiN In distribution
S/BLOCK N BONE LEVEL RC ø4,1-4,8 h.4 TiN In distribution
S/BLOCK N INTEG/OMNIL. ø 3,25 h.3 TiN In distribution
S/BLOCK N BIO HORIZONS ø 3 h.6 TiN In distribution
SET S.BLOCK N. IBS Magicore ø 5 h0,5 In distribution
S/BLOCK N ASTRA LILLA ø 4,5-5 h.6 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 3,25 h.2 TiN In distribution
S/BLOCK N NOBEL ACTIVE NP ø 3,5 h.3 TiN In distribution
SPHERO BLOCK N/BIO HORIZONS ø 5 h.3 TiN In distribution
S/BLOCK N MIS – SEVEN h.1 TiN In distribution
S/BLOCK M ASTRA EV ø 4,2 h.6 TIN In distribution
S/BLOCK N MIS – SEVEN h.3 TiN In distribution
SPHERO BLOCK MICRO CAMLOG ø 3,8 h.2 TiN In distribution
S/B MICRO PRIMA CONNEX ø 3,5 h.1 TiN In distribution
SPHERO BLOCK N/BIO HORIZONS ø 4 h.5 TiN In distribution
SET S.BLOCK N. IBS Magicore ø 5 h2 In distribution
S/BLOCK N BIO HORIZONS ø 3,5 h.5 TiN In distribution
S/BLOCK MICRO OMNILOC 4 h.2 RIV. TiN In distribution
S/BLOCK N ASTRA ST ø 4 h.4 TiN In distribution
S/BLOCK NORMO ASTRA ø 3 h.6 TiN In distribution
SET S.BLOCK N. IBS MAGICORE ø 4 h3 In distribution
SPHERO BLOCK NORMO STRAUMANN ITI h.0,5 TiN In distribution
S/BLOCK N BIO HORIZONS ø 3,5 h.7 TiN In distribution
SPHERO BLOCK N SCREW VENT h.3 TiN In distribution
S/BLOCK M NOBEL ACTIVE NP ø 3,5 h.7 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 3,25 h.4 TiN In distribution
SET S.BLOCK N. NEODENT GM h3 In distribution
S/BLOCK NORMO LEGACY ø 3 h.5 TiN In distribution
SPHERO BLOCK ANYRIDGE h.5 TiN In distribution
S/BLOCK N NOBEL ACTIVE NP ø 3,5 h.2 TiN In distribution
S.BLOCK N.LOCK NEO BIOTECH IS h.2 TiN In distribution
SPHERO BLOCK NORMO BRANEMARK h.4 TiN In distribution
SPHERO BLOCK NORMO BRANEMARK h.2 TiN In distribution
S/BLOCK N BIO HORIZONS ø 3,5 h.4 TiN In distribution
S/ BLOCK NORMO REPL/SELECT ø 5 h.3 TiN In distribution
S. BLOCK N. MEGAGEN BLUE DIAMOND RC h4 In distribution
SPHERO BLOCK NORMO STRAUMANN ITI h.3 TiN In distribution
S/BLOCK NORMO STERI OSS ø 3.8 h.1 TiN In distribution
S/BLOCK N BIO HORIZONS ø 3 h.7 TiN In distribution
S/BLOCK N STRAUMANN ITI WN H 2 TiN In distribution
S/BLOCK NORMO BONE SYSTEM ø 3,7 h.2 TiN In distribution
S/BLOCK M NOBEL ACTIVE ø 3 h.4 TiN In distribution
S/BLOCK NORMO LEGACY ø 3 h.2 TiN In distribution
S/BLOCK NOBEL ACTIVE RP ø 4,3/5 h.5 TiN In distribution
S/BLOCK N SPLINE-TWIST ø ø 3.25 h.2 TiN In distribution
SPHERO BLOCK NORMO XIVE ø 3 h.1 TiN In distribution
S/BLOCK NORMO SUSTAIN E/E ø 3,4 h.2 TiN In distribution
SPHERO BLOCK NORMO XIVE ø 3 h.3 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 3,25 h.6 TiN In distribution
S/BLOCK N PRIMA CONNEX ø 5 h.3 TiN In distribution
S/BLOCK N STRAUMANN ITI WN H 3 TiN In distribution
SPHERO BLOCK ANYRIDGE h.2 TiN In distribution
S/BLOCK N PRIMA CONNEX ø 5 h.1 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 3,25 h.3 TiN In distribution
S/BLOCK N ASTRA LILLA ø 4,5-5 h.05 TiN In distribution
S/BLOCK MICRO CAMLOG ø 4,3 h.3 TiN In distribution
S/BLOCK N PRIMA CONNEX ø 4,1 h.2 TiN In distribution
SPHERO BLOCK ANYRIDGE h.3 TiN In distribution
S/BLOCK MICRO ASTRA EV ø 5,4 h.3 In distribution
S/BLOCK NORMO SPLINE ø 3,75-4 h.5 TiN In distribution
SET S.BLOCK N. IBS MAGICORE ø 4 h1 In distribution
SPHERO BLOCK ANYRIDGE h.1 TiN In distribution
S/BLOCK N STRAUMANN ITI WN H 0.5 TiN In distribution
SPHERO BLOCK NORMO ASTRA EV ø 3,6 h.4 In distribution
S/BLOCK N REPLACE SELECT ø6 h.3 TiN In distribution
S/BLOCK N PRIMA CONNEX ø 5 h.4 TiN In distribution
S/BLOCK N REPL/SELECT ø 4,3 h.0,5 TiN In distribution
S.BLOCK N. C1 Std MIS ø 3,75-4,2 h.4 In distribution
SPHERO BLOCK NORMO IMZ ø 4 h.1 TiN In distribution
SPHERO BLOCK NORMO IMZ ø 3,3 h.5 TiN In distribution
SPHERO BLOCK N SCREW VENT h.1 TiN In distribution
S/BLOCK N ASTRA LILLA ø 4,5-5 h.1 TiN In distribution
SPHERO BLOCK NORMO IMZ ø 4 h.7 TiN In distribution
S/BLOCK N REPLACE SELECT ø6 h.2 TiN In distribution
S/BLOCK N PRIMA CONNEX ø 5 h.1 TiN In distribution
S.BLOCK N. FRIALIT 2 ø 4,5 h.2 TiN In distribution
SPHERO BLOCK ANYRIDGE h.0,6 TiN In distribution
SPHERO BLOCK N SCREW VENT h.7 TiN In distribution
SET S.BLOCK N. BLX RB-WB h2 In distribution
S/BLOCK NORMO BIO VENT ø 4,5 h.3 TiN In distribution
SPHERO BLOCK NORMO NEO h.1 TiN In distribution
SET S.BLOCK N. BLX RB-WB h4 In distribution
S/BLOCK N ASTRA ACQUA ø3,5-4 h.5 TiN In distribution
S/BLOCK N MINIPLANT E/E ø 3,3 h.1,3 TiN In distribution
S/BLOCK NORMO STERI OSS ø 3.8 h.2 TiN In distribution
SPHERO BLOCK N ASTRA EV ø 4,2 h.5 In distribution
SPHERO BLOCK NORMO STRAUMANN ITI h.7 TiN In distribution
SET S.BLOCK N. PRIMACONNEX ø 4.1 h05 In distribution
S/BLOCK NORMO CERTAIN 3I ø 6 h.3 TiN In distribution
S/BLOCK NORMO ASTRA ø 3 h.1 TiN In distribution
S/BLOCK M. BONE LEVEL SC ø 2,9 h.6 TiN In distribution
S/BLOCK M ASTRA EV ø 4,2 h.7 TIN In distribution
S/BLOCK MICRO CAMLOG ø 4,3 h.1 TiN In distribution
S/BLOCK BIO HORIZONS ø 3 h. 0,5 TiN In distribution
S/BLOCK N INTEG/OMNIL. ø 3,25 h.2 TiN In distribution
S/ BLOCK N/BIO HORIZONS ø 6 h.4 TiN In distribution
S.BLOCK NORMO ETIII ø 3,5 h.5 TiN In distribution
S/BLOCK NORMO BIO VENT ø 4.5 h.1 TiN In distribution
S/BLOCK NORMO CERTAIN 3I ø 3,25 h.1 TiN In distribution
SPHERO BLOCK ANKYLOS C/X h.7 In distribution
S/BLOCK NOBEL ACTIVE RP ø 4,3/5 h.4 TiN In distribution
SET S.BLOCK N. BLX RB-WB h5 In distribution
S/BLOCK N NOBEL ACTIVE NP ø 3 h.2 TiN In distribution
S/BLOCK NOBEL ACTIVE RP ø 4,3/5 h.1 TiN In distribution
S/BLOCK N STRAUMANN ITI WN H 1 TiN In distribution
S/BLOCK N STRAUMANN ITI WN H 0 TiN In distribution
SET S.BLOCK N. NEODENT GM h4 In distribution
S/BLOCK NORMO CERTAIN 3I ø 4,1 h.2 TiN In distribution
SPHERO BLOCK N SCREW VENT h.5 TiN In distribution
S/B/MICRO ReplaceSelect ø3,5 h.0,5 TiN In distribution
SPHERO BLOCK NORMO NEO h.3 TiN In distribution
S/BLOCK N ASTRA ST ø 4 h.3 TiN In distribution
S/BLOCK NORMO BRANEMARK h.6 TiN c/TAS In distribution
S/BLOCK N ASTRA LILLA ø 4,5-5 h.2 TiN In distribution
SPHERO BLOCK M ANYRIDGE h.1 TiN In distribution
SPHERO BLOCK NORMO EW h.1mm In distribution
S.BLOCK N. SCREW VENT ø 5,7 h.2 TiN In distribution
SPHERO BLOCK M ANYRIDGE h.6 TiN In distribution
S/BLOCK N STRAUMANN ITI WN H 5 TiN In distribution
SPHERO BLOCK NORMO BRANEMARK h.2 TiN In distribution
SPHERO B/MICRO INTEG/OMN. ø 3,25 h.2 TiN In distribution
SET S.BLOCK N.IBS MEDICORE ø5 h4 In distribution
S/BLOCK N ASTRA ACQUA ø3,5-4 h.7 TiN In distribution
SPHERO BLOCK NORMO STRAUMANN ITI TiN In distribution
S.BLOCK M ENDURE Imtec ø4,3 h.1TiN In distribution
SPHERO BLOCK NORMO CORE VENT h.0.5 TiN In distribution
S/BLOCK N NOBEL ACTIVE NP ø 3 h.1 TiN In distribution
SPHERO BLOCK N CAMLOG ø3,3 h.0.5 RIV.Ti In distribution
S/BLOCK NORMO BIO VENT ø 4.5 h.0.5 TiN In distribution
S/BLOCK N PRIMA CONNEX ø 3,5 h.1 TiN In distribution
S/BLOCK NORMO CAMLOG ø 3,8 h.1 RIV.TiN In distribution
S/BLOCK NORMO ASTRA ø 3 h.3 TiN In distribution
S.BLOCK N.BIO HORIZONS ø 3 h.7 TiN c/tas In distribution
SPHERO B/M CORE VENT h.6 RIV.TiN c/TASS In distribution

Showing 250 of 300 catalogue numbers.

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Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K033630 2004-04-21

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number Decision Trade name Approved to
P800035 2001-10-04 PERI-OSS Curasan AG
P860012 1988-10-28 ALVEOFORM TM BIOGRAFT Collagen Corp.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer