FDA.reportPublic FDA data

IRIS™, Burnout anti rotation cap red (4 pack)

Primary DI
07290116770383
Brand
IRIS™, Burnout anti rotation cap red (4 pack)
Company
ADIN DENTAL IMPLANT SYSTEMS LTD
Model
IR0185
Published
2026-11-01
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

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
07290116770383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116770383072901167703837290116770383

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
533289435
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109308654Single TMA Snap-On TransferRS5012S2026-11-01
07290116770031Depth Probe, Extra Long 16-25mmRS61812026-11-01
07290116770246Single TMA Digital Model Abutment Replica, MachinedRS1001S2026-11-01
07290116770314Guided UniFit Fixture Mount Screw Retained ScrewGS50382026-11-01
07290116770390IRIS™, Burnout cap white (4 pack)IR01862026-11-01
07290116777931TMA Snap-OnTMI00312026-10-26
07290116778686UF Surgical plastic kit, TrayUF63132026-10-26
07290116778709Implant ExtractorRS90502026-10-26
07290116778716TorqLine™ Implant ExtractorRS90512026-10-26
07290116778723UniFit Straight Abutment GaugeUF37102026-10-26
07290116778730UniFit Angled Abutment Gauge 17°UF37112026-10-26
07290116778747UniFit Angled Abutment Gauge 30°UF37122026-10-26
07290116778754UniFit Angled Abutment Gauge 45°UF37132026-10-26
07290116778761UniFit Angled Abutment Gauge 52°UF37142026-10-26
07290116778778UniFit Angled Abutment Gauge 60°UF37152026-10-26
07290116778785Fit Connection - Single Open Tray ImpressionFC5513S2026-10-26
07290116778792Fit Connection - Single Scan Body 6mmFC0088S2026-10-26
07290116778808Fit Connection - Single Scan Body 9mmFC0089S2026-10-26
07290116778815Fit Connection Digital ReplicaFC57382026-10-26
07290116778822Fit Connection 2.2mm Hex Torque Driver - ShortFC00662026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800076476356TruBite ScopeTruabutment Korea Co.,LtdNDP2026-11-03
08800076476486TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476493TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476509TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476516TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
07290109308654Single TMA Snap-On TransferADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770031Depth Probe, Extra Long 16-25mmADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770246Single TMA Digital Model Abutment Replica, MachinedADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770314Guided UniFit Fixture Mount Screw Retained ScrewADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770390IRIS™, Burnout cap white (4 pack)ADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07640169734823BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736056BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736063BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736070BiodentaBiodenta Swiss AGNDP2026-10-30
07899995226273DRIVET RATCHET IMP. CM GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226280DRIVER RATCHET IMP. CM GUI. EST. MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226297DRIVER RATCHET IMP. CM GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226303DRIVER RATCHET IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226327DRIVER C.A. IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226587FIX. SURGICAL GUIDE PALATAL Ø2.0MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234315DEPTH PROBE GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234384HELICAL DRILL Ø1.4MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234629GUIDED INITIAL DRILL Ø2.0X9MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234636GUIDED INITIAL DRILL Ø2.0X5MMSin Sistema de Implante Nacional S/ANDP2026-10-30
08050038833271RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833745RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833752RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833769RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833776RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833783RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30