FDA.reportPublic FDA data

Biotem

Primary DI
08800036202056
Brand
Biotem
Company
Biotem Co., ltd
Model
SAAT45555
Device description
Biotem AR CEMENTED ABUTMENT(HEX) 4.5 mm (D) X 5.0 mm (Cuff) X 5.5 mm (H)
Published
2018-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K171297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171297000AR_N Type Implant SystemBiotem Co., Ltd.2018-01-31DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800036202056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800036202056088000362020568800036202056

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
557793214
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800036261237Bone Pen DrillBPAD02S2025-08-18
08800036261244Bone Pen DrillBPAD02M2025-08-18
08800036261251Bone PinBPP06D202025-08-18
08800036261268Bone PinBPP07D202025-08-18
08800036261275Bone PinBPP08D202025-08-18
08800036261282Bone PinBPP09D202025-08-18
08800036261299Bone PinBPP10D202025-08-18
08800036261305Bone CupBPC06D202025-08-18
08800036261312Bone CupBPC07D202025-08-18
08800036261329Bone CupBPC08D202025-08-18
08800036261336Bone CupBPC09D202025-08-18
08800036261343Bone CupBPC10D202025-08-18
08800036261350Biotem Bone Pen Air KitBPAK2025-08-18
08800036206597BiotemHDB09082018-06-09
08800036206603BiotemHDB09152018-06-09
08800036206610BiotemSD12RS2018-06-09
08800036206627BiotemSD12RL2018-06-09
08800036206634BiotemPP18202018-06-09
08800036206641BiotemFP21H2018-06-09
08800036206658BiotemFP25H2018-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712821017123Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017130Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017147Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017154Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017161Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017178Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017185Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017192Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017208Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017215Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017222Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017239Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017246Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017253Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017260Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017277Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017284Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017291Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017307Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017314Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017321Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017338Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017345Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017352Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HREGOA0Omnibut, Hiossen Regular, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HREGOA140Omnibut, Hiossen Regular, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025MGAOA0Omnibut, MegaGen AnyRidge, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025MGAOA140Omnibut, MegaGen AnyRidge, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26