510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hiossen, Inc.

Fairless Hills, PA, US

HIOSSEN INC. appears in FDA device records in Fairless Hills, PA. FDA records list 26 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
26
PMA records
0
Recall records
7
Registered establishments
4

510(k) clearance history

FDA records hold 26 510(k) clearances for Hiossen, Inc. between 2009 and 2026. The busiest year on record is 2013, with 3. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Hiossen, Inc., by decision year
YearClearances
20092
20102
20111
20121
20133
20141
20163
20171
20182
20193
20221
20231
20242
20251
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHASubstantially Equivalent
K251427EK MULTI ANGLED 30 ABUTMENTNHASubstantially Equivalent
K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)NHASubstantially Equivalent
K240232EK D3.3 and Ultra Wide ImplantsDZESubstantially Equivalent
K233389EK Digital AbutmentsNHASubstantially Equivalent
K222636ET Abutment SystemNHASubstantially Equivalent
K203360EK Implants and Abutments SystemDZESubstantially Equivalent
K191751EM ProvisionalDZESubstantially Equivalent
K191201EM SA Implant SystemDZESubstantially Equivalent
K183242ET IV SA Dental ImplantsDZESubstantially Equivalent
K180527IS3EKXSubstantially Equivalent
K170421ET Hybrid AbutmentNHASubstantially Equivalent
K162390ET Hybrid AbutmentNHASubstantially Equivalent
K153332ETIII SA Fixture System (O3.2mm)DZESubstantially Equivalent
K151542A-OssNPMSubstantially Equivalent
K151626ET III Bio-SA Fixture SystemDZESubstantially Equivalent
K140934HIOSSEN IMPLANT SYSTEMDZESubstantially Equivalent
K132067MULTI ANGLED ABUTMENT SYSTEMNHASubstantially Equivalent
K123471ETII SA FIXTURE SYSTEMDZESubstantially Equivalent
K123627ET SMARTFIT ABUTMENTNHASubstantially Equivalent
K112532ET II BIO-SA FIXTURE SYSTEMDZESubstantially Equivalent
K103537ET III SA ULTRA WIDE SYSTEMDZESubstantially Equivalent
K101096HT III SA FIXTURE SYSTEMDZESubstantially Equivalent
K093889MODIFICATION TO: HG III ULTRA WIDE SYSTEMDZESubstantially Equivalent
K093352HG III FIXTURE SYSTEMDZESubstantially Equivalent
K090237HG II FIXTURE SYSTEMDZESubstantially Equivalent

Registered establishments

FDA registered establishments for Hiossen, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30071354423007135442HIOSSEN INC.85 BEN FAIRLESS DR, Fairless Hills, PA 19030 US2026
30101856353010185635HIOSSEN INC.50 Maple Street, Norwood, NJ 07648 US2026
30174501593017450159HIOSSEN, INC.56-58A East Bridge Street, Morrisville, PA 19067 US2026
30311621233031162123Hiossen, Inc.6940 Beach Blvd, Buena Park, CA 90621 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1276-2025Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA505RV1Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular versionClass IIOpen, Classified
Z-1275-2025ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4524MPPatient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular versionClass IIOpen, Classified
Z-1274-2025Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular versionClass IIOpen, Classified
Z-1273-2025ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MPPatient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular versionClass IIOpen, Classified
Z-1272-2025ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4537MPPatient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular versionClass IIOpen, Classified
Z-1271-2025ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515MPPatient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular versionClass IIOpen, Classified
Z-1604-2023ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010BMis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mmClass IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain