FDA.reportPublic FDA data

On1™

Primary DI
07332747113358
Brand
On1™
Company
Nobel Biocare AB
Model
38700
Catalog number
38700
Device description
On1 Healing Cap WP 2.5 mm
Published
2017-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161655000On1 ConceptNobel Biocare AB2017-02-28NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747113358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747113358073327471133587332747113358

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-5001us.customerservice@nobelbiocare.com

Regulatory Flags#

DUNS number
353939929
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332747214918Nobel Biocare®3019313019312026-04-09
07332747214925Nobel Biocare®3019323019322026-04-09
07332747214932Nobel Biocare®3019333019332026-04-09
07332747214949Nobel Biocare®3019343019342026-04-09
07332747221510Nobel Biocare®3022543022542026-04-09
07332747221527Nobel Biocare®3022553022552026-04-09
07332747221534Nobel Biocare®3022563022562026-04-09
07332747223385Nobel Biocare®3022653022652026-04-09
07332747223392Nobel Biocare®3022643022642026-04-09
07332747223408Nobel Biocare®3022663022662026-04-09
07332747224436Nobel Biocare®3024853024852026-04-09
07332747224443Nobel Biocare®3024863024862026-04-09
07332747224450Nobel Biocare®3024883024882026-04-09
07332747224467Nobel Biocare®3024873024872026-04-09
07332747224474Nobel Biocare®3024893024892026-04-09
07332747224481Nobel Biocare®3024903024902026-04-09
07332747236620DTX Studio™ Clinic4.83008512026-03-27
07332747236637DTX Studio™ Clinic4.83008512026-03-27
07332747219616DTX Studio™ Clinic4.43008512025-01-26
07332747219623DTX Studio™ Clinic4.43008512025-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18