Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612827

FEI Number

3002806508

Entity Name

BIORA AB

City/State/Country

MALMO Skane, SE

Establishment Address

MEDEON SCIENCE PARK, MALMO Skane S-205-12, SE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

INSTITUT STRAUMANN AG (Owner Number: 9005052)

Owner / Operator Contact Address

PETER MERIAN-WEG 12, BASEL, CH-NOTA CH-4002, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040646

PMA Number

N/A

All Registered Proprietary Names

Straumann® PrefGel Straumann BoneCeramic STRAUMANN BONE CERAMIC STRAUMANN BONECERAMIC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2007-12-11
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2021-12-14
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2007-06-29

Official Correspondent

Andreas Petermann

US Agent Details

Jennifer M Jackson Business: Straumann USA, LLC Email: jennifer.jackson@straumann.com Phone: (978) 7472509

Related Public Records

Same Entity

INSTITUT STRAUMANN AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010377510	DENTAL WINGS GMBH	Chemnitz Saxony, DE
1222315	Straumann USA, LLC	ANDOVER, MA, US
3007130440	ClearCorrect , LLC	Round Rock, TX, US
3026444199	Medentika GmbH	Calw Baden-Wurttemberg, DE
3007218081	Straumann Villeret SA	Corgemont Bern, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K052493	Steiner Laboratories	SOCKET GRAFT	2006-06-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2020	Inter-Med Llc	U	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Z-0014-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Z-0015-2020	Inter-Med Llc	U	Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612827. Last updated year: 2026. Please use registration number 9612827 when referencing this establishment in official correspondence.