FDA.report

IPD

Primary DI
08435566600937
Brand
IPD
Company
IMPLANT PROTESIS DENTAL 2004 SL
Model
SC3D
Catalog number
IPD/AA-SW-01
Device description
Scan abutment Non-Engaging Ø 5,1 H 10.0
Published
2023-06-12
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
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435566600937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435566600937084355666009378435566600937

GMDN Terms

TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+13057983869burbina@ipd2004.com

Regulatory Flags

DUNS number
467871518
Device count
1
DM exempt
true
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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