Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042852773

FEI Number

3042852773

Entity Name

COVISION CO., LTD.

City/State/Country

Incheon, KR

Establishment Address

158, Bodeum-ro, Seo-gu, 1102ho, 1113ho, 1114ho, 1115ho, Incheon 22664, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Covision Co., Ltd. (Owner Number: 10094912)

Owner / Operator Contact Address

158, Bodeum-ro, Seo-gu, 1102ho, 1113ho, 1114ho, 1115ho, Incheon, KR-28 22664, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TSBS-0087S TSBS-0065S SBL-0116S 3DAN-0022 TSBL-0126S SBS-006.11S AN-0021 SBS-0012S SD-SL15 TSBL-0012S 3DAN-0089 3DAN-0124 3DAN-0021 3DAN-0083 SBS-0061S 3DAN-0115 AN-0086 SBL-0121S SBS-0083S 3DAN-0125 AN-0108 3DAN-0025 TSBL-0084S SBL-0123S SBL-0015S AN-0025 SBS-0125S SBS-0086S TSBL-0115S SBL-0111S SBL-0126S AN-0102 AN-0023 TSBS-0067S SD-LO10 SD-H1115 TSBL-0014S SBL-006.11S SBL-0114S SBS-0115S SBS-0107S TSBL-0116S TSBL-006.10S AN-0133 SBS-0091S 3DAN-0065 3DAN-0087 SBL-0072S SBS-0134S SD-UNNB25 TSBL-0133S TSBL-0113S SBS-0131S TSBL-0121S TSBS-0089S TSBL-0076S TSBS-0078S TSBS-006.12S SBL-0135S 3DAN-0066 TSBS-0122S 3DAN-0122 TSBL-0082S SBL-0012S TSBS-0063S TSBL-0103S SD-SCS25 SBS-0085S SBL-0022S SD-UNNE10 3DAN-0073 SBL-0017S SBS-0116S SBS-0011S AN-0077 TSBL-006.11S 3DAN-0018 AN-0026 SBS-0023S AN-0104 SBS-0066S AN-0124 3DAN-0012 SBL-0024S 3DAN-0113 AN-0123 SBL-0091S SBS-0017S SBS-0068S AN-0063 SBS-0079S 3DAN-0075 SBL-0133S TSBS-0081S 3DAN-0074 TSBS-0026S TSBS-0083S SBL-0087S AN-0113 SBL-0027S SBS-0022S SBS-008.10S TSBL-0013S TSBS-0012S MASBL48 SBS-0111S SBS-0122S SD-SL10 BSD-SCS15 3DAN-0133 AN-0018 AN-0091 SBL-0073S SD-SCS10 SBL-0083S TSBS-0082S TSBS-0121S TSBL-0135S SD-H2510 SBS-0112S SBS-0014S AN-0083 TSBS-008.10S 3DAN-0061 AN-006.10 TSBS-0027S AN-0061 3DAN-0111 TSBL-0065S SBS-0104S SBL-0102S TSBS-0015S SBL-006.12S TSBL-0079S AN-0106 SD-H12510 AN-0069 SBS-006.12S TSBS-0072S SBS-0063S TSBS-0073S 3DAN-0072 AN-0079 MAAN48 TSBS-0101S AN-0075 3DAN-0063 SBS-0123S AN-0071 3DAN-0114 SBS-0015S TSBS-0135S 3DAN-008.10 TSBS-0086S 3DAN-0086 TSBS-0136S TSBS-0075S 3DAN-0015 TSBL-0106S AN-0116 AN-0068 TSBL-0064S SD-UNND10 TSBS-0105S 3DAN-0131 3DAN-0078 AN-0112 SD-H0917 TSBL-0087S TSBS-0079S AN-0078 TSBS-0132S TSBL-0091S TSBL-0068S TSBS-0102S SBS-0069S SD-H1225 TSBS-0021S SBL-008.10S SBS-0106S SD-UNNB15 TSBL-0086S 3DAN-0126 SD-H12710 SBS-0067S SBL-0125S TSBL-006.12S TSBS-0066S SBS-0088S TSBL-0022S SBS-0113S TSBS-0074S AN-0121 SBS-0071S AN-0015 3DAN-0112 TSBS-006.11S TSBL-0066S TSBL-0077S SBL-0079S SD-LO15 AN-0074 3DAN-0068 SBL-0082S 3DAN-0085 SD-H1410 AN-0089 TSBS-0116S 3DAN-0076 TSBS-0062S 3DAN-0103 AN-0012 TSBS-0071S TSBL-0067S 3DAN-0091 3DAN-0088 TSBL-0101S TSBL-0072S AN-0126 AN-0066 AN-006.12 SBL-0064S AN-0115 TSBS-0068S SBS-0087S SBL-0062S SBL-0124S 3DAN-0071 SBL-0068S TSBL-0136S TSBL-0069S AN-0022 SD-UTDS15 3DAN-0062 SBL-0086S AN-0064 AN-0117 TSBL-0015S SBS-0136S TSBL-0117S SD-SCS15 AN-0027 SD-SQ1010 SBS-0133S SD-SQ1215 SBL-0013S 3DAN-0016 AN-006.11 TSBL-0111S 3DAN-006.11 AN-0011 MAD48S SBL-0081S SD-H1015 SBL-0105S TSBS-0018S SBS-0025S AN-0065 SBL-0021S SD-SQ1210 SBL-0101S TSBS-0025S 3DAN-0027 AN-0076 SBL-0025S 3DAN-0121 3DAN-0069 TSBS-0022S SBL-0061S TSBL-0061S SBL-0026S SD-H12515 AN-008.10 SBS-0082S SBL-0106S SD-UNNE15 TSBS-0016S 3DAN-0135 AN-0014 TSBL-0073S SBL-0084S 3DAN-0102 AN-0114 TSBL-0088S SD-H1010 SBL-0016S 3DAN-0084 3DAN-0082 SBS-0072S SBL-0089S AN-0017 TSBL-0027S TSBL-0018S 3DAN-0081 SBL-0108S TSBL-0026S 3DAN-0107 AN-0016 TSBS-0111S SBS-0027S TSBS-0117S SBS-0105S SBS-0114S SBS-0103S AN-0105 SBL-0023S SBL-0117S TSBS-0104S SBS-0135S AN-0073 SBL-0077S SBL-0078S SBL-0066S SBS-0016S TSBS-0126S SBS-0084S AN-0062 AN-0087 SBL-0132S SD-H1215 SBS-0126S SD-H1210 SD-UNDS10 AN-0013 AN-0111 TSBS-0107S AN-0132 TSBL-0024S SBL-0071S TSBS-0088S AN-0072 SD-H1110 TSBS-0125S SBS-0081S 3DAN-0017 TSBL-0131S SD-H12715 SBL-0134S SBL-0113S SBL-0018S 3DAN-0108 SBL-0136S 3DAN-0123 SD-UNND15 TSBS-0077S SBL-0088S 3DAN-0013 SBS-0121S SBL-0075S SBL-0122S 3DAN-0024 TSBL-0108S 3DAN-0106 SBS-0075S SBS-0124S SBS-0089S MASBS48 SD-H1415 TSBS-0013S AN-0081 TSBL-0104S AN-0088 TSBS-0061S TSBL-0075S TSBS-0017S SBS-0065S AN-0136 TSBS-0091S AN-0134 AN-0107 SBL-0115S TSBL-0102S SD-H0910 SBS-0077S 3DAN-0011 SBS-0132S SBS-0026S SBS-0074S SBS-0102S SBS-0078S TSBS-0133S TSBS-0106S TSBL-0132S TSBS-0014S MAICS48S SD-H2515 TSBL-0107S 3DAN-0101 TSBS-0103S TSBS-0114S SBL-0131S TSBL-0124S TSBL-0017S 3DAN-0134 TSBL-008.10S 3DAN-0105 3DAN-0026 3DAN-006.12 TSBL-0078S 3DAN-0064 TSBS-0124S TSBS-0024S TSBL-0011S AN-0084 SBL-0014S TSBS-0011S TSBL-0016S SBS-0018S SBS-0076S TSBS-0131S SBL-0063S TSBS-0112S 3DAN-006.10 TSBS-0134S TSBS-0113S TSBS-0085S AN-0103 SBL-006.10S TSBL-0062S SBL-0107S 3DAN-0079 SBS-0062S SBS-0073S TSBL-0025S TSBS-0069S TSBL-0089S TSBL-0125S TSBL-0071S AN-0082 TSBL-0021S TSBL-0083S SBS-0101S AN-0122 TSBL-0063S TSBL-0085S TSBL-0105S BSD-SCS10 AN-0135 AN-0131 TSBS-0123S TSBL-0114S SBS-006.10S SBS-0024S SBS-0013S SBS-0108S 3DAN-0116 TSBS-0064S SBL-0067S SBL-0076S 3DAN-0136 SBL-0112S SBL-0074S SBL-0103S SBL-0104S SBL-0069S SD-H0912 TSBL-0122S TSBL-0112S TSBL-0123S 3DAN-0014 SD-H12725 SBS-0117S SD-H0915 TSBS-0108S SD-SQ1015 TSBL-0081S TSBL-0023S TSBS-006.10S 3DAN-0067 AN-0024 AN-0085 TSBS-0115S 3DAN-0132 SBL-0011S 3DAN-0077 SBS-0021S 3DAN-0104 SBL-0085S TSBS-0076S TSBS-0023S AN-0125 AN-0101 TSBL-0134S AN-0067 3DAN-0117 TSBL-0074S SD-UNNB10 TSBS-0084S SBL-0065S 3DAN-0023 SBS-0064S MAICS48L

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2026-01-06

Official Correspondent

woonbee Jeong

US Agent Details

HYUN JU KIM Email: freddhkim@gmail.com Phone: (714) 3653704

Related Public Records

Same Entity

Covision Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
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3042200066	HUB BIOTECH CO., LTD.	BUCHEON-SI Gyeonggi, KR
3009847764	GMI DENTAL IMPLANTOLOGY, S.L.	Lleida Lerida, ES
3030863060	OSSEO PURE INC	Lancaster, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042852773. Last updated year: 2026. Please use registration number 3042852773 when referencing this establishment in official correspondence.