FDA.reportPublic FDA data

OrangeCAD Med

Primary DI
04262365195470
Brand
OrangeCAD Med
Company
OrangeCAD MED GmbH
Model
SMBL5701H
Catalog number
SMBL5701H
Device description
Multi-Unit Cover cap
Published
2026-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253312000OrangeCAD Med AbutmentsOrangecad Med GmbH2025-12-23NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262365195470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262365195470042623651954704262365195470

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
343793874
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04262365191120OrangeCAD MedSMBL2707HSMBL2707H2026-01-09
04262365191502OrangeCAD MedSMBL2706HSMBL2706H2026-01-09
04262365191540OrangeCAD MedSMBL2705HSMBL2705H2026-01-09
04262365191557OrangeCAD MedSMBL2704HSMBL2704H2026-01-09
04262365191564OrangeCAD MedSMBL2703HSMBL2703H2026-01-09
04262365191571OrangeCAD MedSMBL2708HSMBL2708H2026-01-09
04262365192790OrangeCAD MedSMBL5010HSMBL5010H2026-01-09
04262365192943OrangeCAD Med31.023.71.031H31.023.71.031H2026-01-09
04262365193537OrangeCAD Med31.025.23.031H31.025.23.031H2026-01-09
04262365193551OrangeCAD Med31.022.71.025H31.022.71.025H2026-01-09
04262365193575OrangeCAD Med31.024.23.025H31.024.23.025H2026-01-09
04262365194084OrangeCAD MedSMBL5201HSMBL5201H2026-01-09
04262365195104OrangeCAD Med31.030.00.188H31.030.00.188H2026-01-09
04262365195210OrangeCAD Med31.064.71.031H31.064.71.031H2026-01-09
04262365195364OrangeCAD MedSMBL5301HSMBL5301H2026-01-09
04262365195593OrangeCAD MedSMBL5601HSMBL5601H2026-01-09
04262365195746OrangeCAD MedSMBL5003HSMBL5003H2026-01-09
04262365195906OrangeCAD MedIPS-14-41IPS-14-412026-01-09
04262365195913OrangeCAD MedSMBL5401HSMBL5401H2026-01-09
04262365195920OrangeCAD Med31.063.71.025H31.063.71.025H2026-01-09

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