FDA.reportPublic FDA data

IMTEC

Primary DI
D769IM2017CO0
Brand
IMTEC
Company
PARK DENTAL RESEARCH CORP
Model
IM-2017-CO
Catalog number
2017-CO
Device description
Lew MDI Implant Collared
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121707000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121707000LEW MDI O-BALL COLLARED IMPLANT,Park Dental Research Corp.2012-09-24DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D769IM2017CO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-243-7372info@pdrus.com

Regulatory Flags#

DUNS number
011441508
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D769SVKIT0IMTEC SVKIT2026-04-28
D769IMSVKITMT0IMTEC IM-SVKIT-MTSVKIT-MT2024-08-20
D769PDAIAL0Park Dental Research Corp.PDA-IALPDA-IAL2023-02-20
D769CMALIGN0Clear MovesCM-ALIGN2026-04-15
D769CMRETAIN0Clear MovesCM-RETAIN2026-04-15
D769WLALIGN0White LabelWL-ALIGN2026-04-15
D769WLRETAIN0White LabelWL-RETAIN2026-04-15
D769ORCALIGN0Orchestrate 3DORC-ALIGN2026-04-14
D769ORCRETAIN0Orchestrate 3DORC-RETAIN2026-04-14
D769PDAALIGN0Park Dental PDA-ALIGN2026-04-14
D769PDARETAIN0Park Dental PDA-RETAIN2026-04-14
D769CMIAL0Clear MovesCM-IAL2025-12-16
D769O3D0Orchestrate 3DO3D2025-07-17
D769P45450IMTEC IM-P4545P45452025-05-13
D769XP45450IMTEC IM-XP4545XP45452025-05-13
D769P45410IMTEC IM-P4541P45412025-05-12
D769P45430IMTEC IM-P4543P45432025-05-12
D769XP45410IMTEC IM-XP4541XP-45412025-05-12
D769XP45430IMTEC IM-XP4543XP45432025-05-12
D7693510MOB0IMTEC 3510-MOB3510-MOB2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532000430Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000874Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037115Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037122Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049613Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049620Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049637Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067778ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532067785ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532000928ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532000935ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002649ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002656ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16
07392532002663ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-16