FDA.reportPublic FDA data

Single Arch Dam Conversion Kit 1PK, ZimVie

Primary DI
D990ZVSADCK1PK0
Brand
Single Arch Dam Conversion Kit 1PK, ZimVie
Company
SMART DENTURE CONVERSIONS, LLC
Model
ZV-SADCK1PK
Published
2026-06-26
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
EIEDam, Rubber
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIEDam, RubberDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D990ZVSADCK1PK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture clasp, polymer, preformedA prefabricated dental device made of polymer material intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
010613514
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D990EK2A0Essentials Kit, 2 ArchEK2A2026-07-13
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GH25HMINI-OA2026-06-26
D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.425HMINI-OA1.42026-06-26
D99025HREGOA0Omnibut, Hiossen Regular, 2.5GH25HREG-OA2026-06-26
D99025HREGOA140Omnibut, Hiossen Regular, 2.5GH, M1.425HREG-OA1.42026-06-26
D99025MGAOA0Omnibut, MegaGen AnyRidge, 2.5GH25MGA-OA2026-06-26
D99025MGAOA140Omnibut, MegaGen AnyRidge, 2.5GH, M1.425MGA-OA1.42026-06-26
D99025TINT37OA0Omnibut, Tatum Integrity 3.7, 2.5GH25TINT37-OA2026-06-26
D99025TINT37OA140Omnibut, Tatum Integrity 3.7, 2.5GH, M1.425TINT37-OA1.42026-06-26
D99025TINT50OA0Omnibut, Tatum Integrity 5.0, 2.5GH25TINT50-OA2026-06-26
D99025TINT50OA140Omnibut, Tatum Integrity 5.0, 2.5GH, M1.425TINT50-OA1.42026-06-26
D99025TINT60OA0Omnibut, Tatum Integrity 6.0, 2.5GH25TINT60-OA2026-06-26
D99025TINT60OA140Omnibut, Tatum Integrity 6.0, 2.5GH, M1.425TINT60-OA1.42026-06-26
D99038BLXOA0Omnibut, Straumann BLX, 3.8GH38BLX-OA2026-06-26
D99038BLXOA140Omnibut, Straumann BLX, 3.8GH, M1.438BLX-OA1.42026-06-26
D99038HMINIOA0Omnibut, Hiossen Mini, 3.8GH38HMINI-OA2026-06-26
D99038HMINIOA140Omnibut, Hiossen Mini, 3.8GH, M1.438HMINI-OA1.42026-06-26
D99038HREGOA0Omnibut, Hiossen Regular, 3.8GH38HREG-OA2026-06-26
D99038HREGOA140Omnibut, Hiossen Regular, 3.8GH, M1.438HREG-OA1.42026-06-26
D99038IH35OA0Omnibut, Internal Hex 3.5, 3.8GH38IH35-OA2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532032349Bone TrapDentsply Implants Manufacturing GmbHNDP2026-10-16
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08809918259713LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
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03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07