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Osteon II

by GENOSS CO., Ltd.

510(k) K112716

Osteon II is a Class II device made by GENOSS CO., Ltd., cleared under FDA 510(k) K112716 on 17 Jan 2012, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK112716 Date17 Jan 2012ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LYC
Device class
Class II
Regulation
21 CFR Part 872.3930
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K112716

81 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K112716
UDI-DISize and differences
OSTEON II DT7G0205100
Genoss
DT7G0205100 / DT7G020510008809324764108
Total Volume 1 mL
On the market
OSTEON II DT7G0205300
Genoss
DT7G0205300 / DT7G020530008809324764122
Total Volume 3 mL
On the market
OSTEON II DT7G0205400
Genoss
DT7G0205400 / DT7G020540008809324764139
Total Volume 4 mL
On the market
OSTEON II DT7G0210010
Genoss
DT7G0210010 / DT7G021001008809324764153
Total Volume 0.1 mL
On the market
OSTEON II DT7G0210025
Genoss
DT7G0210025 / DT7G021002508809324764160
Total Volume 0.25 mL
On the market
OSTEON II DT7G0210050
Genoss
DT7G0210050 / DT7G021005008809324764177
Total Volume 0.5 mL
On the market
OSTEON II DT7G0210100
Genoss
DT7G0210100 / DT7G021010008809324764184
Total Volume 1 mL
On the market
OSTEON II DT7G0210200
Genoss
DT7G0210200 / DT7G021020008809324764191
Total Volume 2 mL
On the market
OSTEON II DT7G0210500
Genoss
DT7G0210500 / DT7G021050008809324764221
Total Volume 5 mL
On the market
OSTEON II DT7G0510100
Genoss
DT7G0510100 / DT7G051010008809324764269
Total Volume 1 mL
On the market
OSTEON II DT7G0510300
Genoss
DT7G0510300 / DT7G051030008809324764283
Total Volume 3 mL
On the market
OSTEON II DT7G0510500
Genoss
DT7G0510500 / DT7G051050008809324764306
Total Volume 5 mL
On the market
OSTEON II DT7G1020010
Genoss
DT7G1020010 / DT7G102001008809324764313
Total Volume 0.1 mL
On the market
OSTEON II DT7G1020200
Genoss
DT7G1020200 / DT7G102020008809324764351
Total Volume 2 mL
On the market
OSTEON II DT7G1020300
Genoss
DT7G1020300 / DT7G102030008809324764368
Total Volume 3 mL
On the market
OSTEON II DT7G1020400
Genoss
DT7G1020400 / DT7G102040008809324764375
Total Volume 4 mL
On the market
OSTEON II DT7G1020500
Genoss
DT7G1020500 / DT7G102050008809324764382
Total Volume 5 mL
On the market
OSTEON II DT7G2030010
Genoss
DT7G2030010 / DT7G203001008809324764399
Total Volume 0.1 mL
On the market
OSTEON II DT7G2030100
Genoss
DT7G2030100 / DT7G203010008809324764429
Total Volume 1 mL
On the market
OSTEON II DT7G2030300
Genoss
DT7G2030300 / DT7G203030008809324764443
Total Volume 3 mL
On the market
OSTEON II DT7G2030400
Genoss
DT7G2030400 / DT7G203040008809324764450
Total Volume 4 mL
On the market
OSTEON II DT7G2030500
Genoss
DT7G2030500 / DT7G203050008809324764467
Total Volume 5 mL
On the market
OSTEON II DT7G2040050
Genoss
DT7G2040050 / DT7G204005008809324764498
Total Volume 0.5 mL
On the market
OSTEON II DT7G2040100
Genoss
DT7G2040100 / DT7G204010008809324764504
Total Volume 1 mL
On the market
OSTEON II DT7G2040200
Genoss
DT7G2040200 / DT7G204020008809324764511
Total Volume 2 mL
On the market
OSTEON II DT7G2040300
Genoss
DT7G2040300 / DT7G204030008809324764528
Total Volume 3 mL
On the market
OSTEON II DT7G2040400
Genoss
DT7G2040400 / DT7G204040008809324764535
Total Volume 4 mL
On the market
OSTEON II DT7G2040500
Genoss
DT7G2040500 / DT7G204050008809324764542
Total Volume 5 mL
On the market
OSTEON II DT7G3040010
Genoss
DT7G3040010 / DT7G304001008809324764559
Total Volume 0.1 mL
On the market
OSTEON II DT7G3040050
Genoss
DT7G3040050 / DT7G304005008809324764573
Total Volume 0.5 mL
On the market
OSTEON II DT7G3040200
Genoss
DT7G3040200 / DT7G304020008809324764597
Total Volume 2 mL
On the market
OSTEON II DT7G3040300
Genoss
DT7G3040300 / DT7G304030008809324764603
Total Volume 3 mL
On the market
OSTEON II DT7G3050010
Genoss
DT7G3050010 / DT7G305001008809324764634
Total Volume 0.1 mL
On the market
OSTEON II DT7G3050050
Genoss
DT7G3050050 / DT7G305005008809324764658
Total Volume 0.5 mL
On the market
OSTEON II DT7G3050100
Genoss
DT7G3050100 / DT7G305010008809324764665
Total Volume 1 mL
On the market
OSTEON II DT7G3050300
Genoss
DT7G3050300 / DT7G305030008809324764689
Total Volume 3 mL
On the market
OSTEON II DT7G3050400
Genoss
DT7G3050400 / DT7G305040008809324764696
Total Volume 4 mL
On the market
OSTEON II DT7G3050500
Genoss
DT7G3050500 / DT7G305050008809324764702
Total Volume 5 mL
On the market
OSTEON II DT7G4050010
Genoss
DT7G4050010 / DT7G405001008809324764719
Total Volume 0.1 mL
On the market
OSTEON II DT7G4050025
Genoss
DT7G4050025 / DT7G405002508809324764726
Total Volume 0.25 mL
On the market
OSTEON II DT7G4050050
Genoss
DT7G4050050 / DT7G405005008809324764733
Total Volume 0.5 mL
On the market
OSTEON II DT7G4050100
Genoss
DT7G4050100 / DT7G405010008809324764740
Total Volume 1 mL
On the market
OSTEON II DT7G4050200
Genoss
DT7G4050200 / DT7G405020008809324764757
Total Volume 2 mL
On the market
OSTEON II DT7G4070010
Genoss
DT7G4070010 / DT7G407001008809324764795
Total Volume 0.1 mL
On the market
OSTEON II DT7G4070025
Genoss
DT7G4070025 / DT7G407002508809324764801
Total Volume 0.25 mL
On the market
OSTEON II DT7G4070100
Genoss
DT7G4070100 / DT7G407010008809324764825
Total Volume 1 mL
On the market
OSTEON II DT7G4070300
Genoss
DT7G4070300 / DT7G407030008809324764849
Total Volume 3 mL
On the market
OSTEON II DT7G4070500
Genoss
DT7G4070500 / DT7G407050008809324764863
Total Volume 5 mL
On the market
OSTEON ll Sinus DT7G0510050SS
Genoss
DT7G0510050SS / DT7G0510050SS08809324765082
Total Volume 0.5 mL
On the market
OSTEON ll Sinus DT7G1020050SS
Genoss
DT7G1020050SS / DT7G1020050SS08809324765105
Total Volume 0.5 mL
On the market

Similar devices

Other devices filed under FDA product code LYC (Bone Grafting Material, Synthetic).

Other devices from GENOSS CO., Ltd.

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