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Singapore HSA registration DE0509346

MIS OT-Equators & Ball Attachments System

Singapore flagSingapore·CLASS C·MIS implants Technologies Ltd.·Registered June 04, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration information
Registration Number
DE0509346
Registration Date
June 04, 2024
Retention Due Date
June 03, 2025
Product description
Dental implant abutments are intended to be used in the upper or lower jaw used for supporting tooth replacements to restore chewing function. The abutments in combination with two-stage endosseous implants are intended to be used as a foundation for anchoring tooth replacements in either jaw. For fully edentulous jaw retaining a tissue-supported overdenture.
Product Owner
Name
MIS implants Technologies Ltd.
Short Name
MIS implants Technologies Ltd.
Address
P.O. Box 7, Bar Lev Industrial Park, 2015600, ISRAEL
Registrant
Name
DENTSPLY SIRONA SINGAPORE PTE LTD
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
Name
DENTSPLY SIRONA SINGAPORE PTE LTD
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Model information
Model Name(s)
OT Equator coni. con. kit, gingiva height 1mm, NP OT Equator coni. con. kit, gingiva height 2mm, NP OT Equator coni. con. kit, gingiva height 3mm, NP OT Equator coni. con. kit, gingiva height 4mm, NP OT Equator coni. con. kit, gingiva height 5mm, NP OT Equator coni. con. kit, gingiva height 1mm, SP OT Equator coni. con. kit, gingiva height 2mm, SP OT Equator coni. con. kit, gingiva height 3mm, SP OT Equator coni. con. kit, gingiva height 4mm, SP OT Equator coni. con. kit, gingiva height 5mm, SP OT Equator coni. con. kit, gingiva height 1mm, WP OT Equator coni. con. kit, gingiva height 3mm, WP Ball attachment anchor 1mm coni. con., NP Ball attachment anchor 2mm coni. con., NP Ball attachment anchor 3mm coni. con., NP Ball attachment anchor 4mm coni. con., NP Coni. con. ball attachment anchor 1mm, WP Coni. con. ball attachment anchor 3mm, WP OT Equator int. hex. kit, gingiva height 1mm, NP OT Equator int. hex. kit, gingiva height 2mm, NP OT Equator int. hex. kit, gingiva height 3mm, NP OT Equator int. hex. kit, gingiva height 4mm, NP OT Equator int. hex. kit, gingiva height 5mm, NP OT Equator int. hex. kit, gingiva height 1mm, SP OT Equator int. hex. kit, gingiva height 2mm, SP OT Equator int. hex. kit, gingiva height 3mm, SP OT Equator int. hex. kit, gingiva height 4mm, SP OT Equator int. hex. kit, gingiva height 5mm, SP OT Equator int. hex. kit, gingiva height 1mm, WP OT Equator int. hex. kit, gingiva height 3mm, WP OT Equator metal housing OT-Equator laboratory retentive cap (black) OT Equator soft retentive cap (pink) OT Equator rigid retentive cap (violet) OT Equator standard retentive cap (white) OT Equator extra soft retentive cap (yellow)
Model Identifier(s)
CK-NOE1 CK-NOE2 CK-NOE3 CK-NOE4 CK-NOE5 CK-SOE1 CK-SOE2 CK-SOE3 CK-SOE4 CK-SOE5 CK-WOE1 CK-WOE3 CN-B1330 CN-B2330 CN-B3330 CN-B4330 CW-B1500 CW-B3500 MK-NOE1 MK-NOE2 MK-NOE3 MK-NOE4 MK-NOE5 MK-SOE1 MK-SOE2 MK-SOE3 MK-SOE4 MK-SOE5 MK-WOE1 MK-WOE3 OE-MH001 OE-RCB01 OE-RCP01 OE-RCV01 OE-RCW01 OE-RCY01
About this record

Access comprehensive regulatory information for MIS OT-Equators & Ball Attachments System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509346 and owned by MIS implants Technologies Ltd.. The device was registered on June 04, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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