FDA.reportPublic FDA data

IMTEC

Primary DI
D769IMCASE40
Brand
IMTEC
Company
PARK DENTAL RESEARCH CORP
Model
IM-CASE-4
Catalog number
CASE-4
Device description
Lew MDI Case
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
D769IMCASE40PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
08800070230008ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-07-29
08800070201619ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218600ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218891ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070228333ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
07290116155630PF-Pro ImplantNORIS MEDICAL LTDDZE2026-06-25
07290116155647PF-Pro ImplantNORIS MEDICAL LTDDZE2026-06-25
07290116155654PF-Pro ImplantNORIS MEDICAL LTDDZE2026-06-25
07290116155661PF-Pro ImplantNORIS MEDICAL LTDDZE2026-06-25
07290116155678PF-Pro ImplantNORIS MEDICAL LTDDZE2026-06-25