FDA.report

IPD

Primary DI
08435566601262
Brand
IPD
Company
IMPLANT PROTESIS DENTAL 2004 SL
Model
TI
Catalog number
IPD/AB-CR-01
Device description
Closed Tray impression coping Ø 4,8
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435566601262PrimaryGS10

GMDN Terms

TermDefinition
Dental prosthesis/implant abutment screw analog, reusableA device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+13057983869burbina@ipd2004.com

Regulatory Flags

DUNS number
467871518
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08435566602719IPDTTIPD/AC-TN-002026-01-30
08435566602764IPDTTIPD/AC-TR-002026-01-30
08435566616464IPDTTIPD/JA-TR-002026-01-30
08435566619465IPDTTIPD/MB-TN-002026-01-30
08435566621482IPDTTIPD/QB-TR-002026-01-30
08435566623004IPDTTIPD/SB-TR-002026-01-30
08435566625992IPDTTIPD/YB-TR-002026-01-30
08435566629693IPDTTIPD/JB-TR-002026-01-30
08435566635823IPDTTIPD/JA-TX-002026-01-30
08435566638831IPDPREMIPD/JA-XN-002026-01-30
08435566638848IPDPREMIPD/JA-XR-002026-01-30
08435566638855IPDPREMIPD/JA-XW-002026-01-30
08435566638862IPDPREMIPD/JA-XX-002026-01-30
08435566638879IPDPREMIPD/DB-XN-002026-01-30
08435566638886IPDPREMIPD/DB-XR-002026-01-30
08435566638893IPDPREMIPD/EB-XT-002026-01-30
08435566638909IPDPREMIPD/EB-XN-002026-01-30
08435566638916IPDPREMIPD/EB-XR-002026-01-30
08435566638923IPDPREMIPD/EB-XW-002026-01-30
08435566638930IPDPREMIPD/EB-XX-002026-01-30

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