FDA.reportPublic FDA data

IPD

Primary DI
08435566616921
Brand
IPD
Company
IMPLANT PROTESIS DENTAL 2004 SL
Model
AINC3D
Catalog number
IPD/KR-IR-65
Device description
Cutting guide Non-Engaging Regular H 6.5
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435566616921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435566616921084355666169218435566616921

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure reamer guideA manually-operated dental laboratory instrument intended to help guide a manual reamer during smoothing and refining of the surface of the screw channel, screw seat and implant/abutment connection of a dental implant suprastructure, to remove minor casting flashes during the production of a final suprastructure; it is not intended for intraoral use. Also referred to as a reamer gauge, it is in the form of a support with a flat base and slots for mounting the suprastructure and inserting the reamer. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800020802767ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802859SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802866SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802873SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802880SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802897SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802903SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802927SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802934SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803009SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803016SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803023SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803047SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803054SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020858948ABIDING MU LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020859372ABIDING COUPLE DIGITAL LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26